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Development Resource Group

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Category : Test Engr - Technical
Job Type : Permanent
Id : 8515
Region : Twin Cities

The In-Circuit Test Engineer is responsible for creating test files and performing tester checkout of in-circuit test (ICT) fixture hardware. Assists the production team with the debug and rework of test fixtures which fail ICT.

Major Areas of Accountability:

  • Create basic test files for checkout of test fixtures on one or more ICT platforms.
  • Perform tester checkout on completed ICT fixtures.
  • Support debug and rework of fixtures which do not pass on the ICT platform.
  • Track defect rates for product tested on the ICT platforms.
  • Work proactively with the production team to reduce defects and improve yield.
  • Provide programming for customers looking for turnkey solutions on GenRad 228X and Teradyne ICT platforms, as required.
  • Perform installation, testing, and debug of test fixtures at customer sites, as required.

Education and Experience:

  • Bachelor’s Degree in Electrical Engineering, Computer Science, or equivalent experience in a test engineering environment
  • Experience developing test files for GenRad 228X, Teradyne Z189X, and Teradyne 8800 spectrum series ICT platforms
  • 5 or more years of experience working in an electromechanical manufacturing environment

Knowledge, Skills, and Abilities Required:

  • Strong electronic engineering fundamentals; able to perform root cause failure analysis
  • Excellent verbal and written communication skills
  • Excellent data analysis and presentation skills
  • Great teamwork and interpersonal skills
  • Ability to travel within the US
  • Proven ability to manage working on multiple projects at a time while paying strict attention to detail
  • Proficiency with Microsoft Office Suite
  • Maintains confidentiality and security of intellectual property (ITAR, Prototype)


Posted: October 22, 2021, 12:59 pm
Category : Firmware Engineer
Job Type : Permanent
Id : 8514
Region : Twin Cities

We are seeking a Lead Embedded Linux Software Engineer who has an interest in home automation and a penchant for tech gadgets, IoT and splendid user experiences. You will work closely with our CTO and Product Management team to innovate our customer focused solutions.

What you will be doing:

  • Developing Linux applications for embedded devices and systems
  • Designing our next generation graphic interface
  • Creating software that brings customer and business requirements to life
  • Innovating our award-winning line of products

Required Qualifications:

  • A desire to want to do cool things and have fun while doing it!
  • A BS in Computer Science or a related technical field
  • 5+ years of professional embedded Linux development
  • Demonstrable proficiency in C/C++ software design
  • Experience with GIT or comparable source control software
  • Familiar with MCU and SOC architectures
  • Highly desirable to have a solid understanding and practical experience with Networking communication, Ethernet and wireless TCP/IP and UDP

Preferred Qualifications:

  • Experience using YOCTO or other build systems
  • GUI design experience (Ensemble or similar)
  • Contract engineering experience a plus
  • Experience developing software in the Agile framework
  • RTOS development experience
  • Wireless communications (Wi-Fi, Bluetooth, ZigBee, Z-Wave)
  • Experience with task tracking tools (JIRA)
  • Experience developing IoT / smart home devices


Posted: October 22, 2021, 9:56 am
Category : Technicians
Job Type : Permanent
Id : 8513
Region : Twin Cities

Seeking a Manufacturing Engineer Technician to provide technical support for assembly and RMA functions as well as develop assembly and test procedures. To build, document, and maintain factory production and testing equipment.

Qualifications:

  • At least 2 years of Technical College training in fluid power, robotics, electronics technology or a related field.
  • At least 3 years of related work experience in a manufacturing environment.
  • Strong mechanical and electrical aptitude and problem solving skills.
  • Displays a positive attitude and a strong desire to grow.
  • Ability to communicate and work well with others.
  • Ability to write technical documentation.
  • Demonstrated ability to solve problems in a timely and effective manner.
  • Ability to provide effective equipment documentation.


Posted: October 21, 2021, 8:14 am
Category : Software Engineering
Job Type : Contract
Id : 8512
Region : Twin Cities

Seeking a creative Research Software Engineer or scientist with solid practical software experience, superior communication skills, and a keen desire to learn all aspects Cardiac Mapping System.  Working primarily with software engineers, you will learn to build and deploy the baseline commercial version of the software.  You will then work closely with scientists and engineers in Applied Research and in Human Factors Engineering to help define, prototype, and refine new algorithms and GUI components and incorporate them into new versions of research software.  You will participate in benchtop and preclinical testing to validate your ideas, interact directly with customers to hear and understand their feedback, and help to transfer features into future versions of commercial software.  Your work will result in valuable intellectual property, and you will know that your efforts directly advance the state of the art and help to better diagnose and treat patients with cardiac arrhythmias. 

 

RESPONSIBILITIES:

  • Work with Software Development engineers to understand the overall software architecture and to keep current with the process to create custom research builds of system software.
  • Work with Applied Research scientists and engineers to understand, prototype, and refine a wide variety of signal processing and 3D graphics algorithms, and to incorporate new algorithm ideas into research versions of software.
  • Work with Human Factors engineers to understand, prototype, and refine GUI concepts, and to incorporate them into research versions of software.
  • Test algorithms and GUI concepts through hands-on bench testing and participation in preclinical procedures.
  • Document the design and performance of new features in clearly written reports and participate in reviews with cross-functional teams.  
  • Provide support for invention disclosures and research publications.

 

REQUIRED QUALIFICATIONS:

  • A B.S., M.S. or PhD Degree in any science or engineering discipline.
  • At least 2 years of practical software experience specifically using C++.
  • Good working knowledge of Linux and SW development tools such as Visual Studio, Jira, Perforce.
  • Strong technical communication skills including spoken and written English. 

 

OTHER USEFUL QUALIFICATIONS:

  • GUI development and/or prototyping experience with Qt/QML, Axure, Adobe XD, or similar tools
  • Strong background in mathematics, practical experience with signal processing.
  • Experience with multithreading, OpenGL graphics, Matlab, Python, statistical analysis. 
  • Experience with medical device development, especially related to cardiac electrophysiology. 


Posted: October 21, 2021, 8:09 am
Category : Quality Engineering
Job Type : Contract
Id : 8506
Region : Twin Cities

We're looking for a Quality Engineer I or II with the following experience:

 

Skills:

  • Excellent verbal and written communication skills
  • Interpersonal skills, team player
  • Individual contributor
  • Multi- tasking
  • Strong organizational skills
  • Advanced computer skills

Education/Experience:

  • Bachelor level degree in an Engineering Discipline or other technical field
  • 1 – 5 years of work experience,or internship experience 

Duties:

  • Participate in or lead teams in supporting quality disciplines, decisions, and practices, lead on-time completions of design control deliverables, support on-time execution of Quality Plans for internal product development process (PDP), OEM-based Clinical Product Development (CPDP) and design change projects.
  • Accountable for generation of PDP design verification test plans/reports for product/system requirements, lead or support Risk. Management activities from product concept through commercialization, including generation of risk management plans/reports, completion and maintenance of hazard analysis.
  • FMECA's and Cybersecurity risk assessments, lead identification of essential outputs and generate Essential Output reports.
  • Accountable for completion of labeling verification activities and labeling verification reports, work with design engineering in the completion of customer/system/product requirements.
  • Work with design engineering in the completion of product verification and validation.
  • Endure DHF content completion, integrity and regulatory & standards compliance.
  • Collaborative communication in resolving gaps.
  • Complete document change request reviews in a timely and objective manner.
  • Identify and implement effective process control systems to support the development, qualification and on-going manufacturing of products to meet or exceed internal and external requirements.
  • Assist in the implementation of assurances, process controls and CAPA systems designed to meet or exceed internal and external requirements.
  • Assist in tech development and execution of streamlined business systems which effectively identify and resolve quality issues.
  • Apply sound, systematic problem solving methodologies in identifying, prioritizing, communicating and resolving quality issues.
  • Support all company initiatives as identified by management and in support of quality management systems (QMS), Environmental Management Systems (EMS) and other regulatory requirements.
  • Additional duties may be identified by functional management based on the current project/business objectives.

 

 


 

Posted: October 21, 2021, 4:36 am
Category : Software Engineer
Job Type : Contract
Id : 8505
Region : Twin Cities

Looking for a Software Engineer to join a R&D Organization to support software systems engineering processes and testing of application and embedded software for Medical Device systems. The Software Engineer will also be responsible for supporting the design of processes, tools, documentation, and automated test systems to support this effort.

Areas of responsibilities may include creating design documentation such as architecture, design, and interface specifications for application and embedded software; writing, reviewing, and releasing requirements and test procedures; execution of manual testing and test automation in C#; and supporting a remote/offshore team doing application software testing design and execution. The candidate will drive manual, semi-automated, and automated testing to be implemented depending on automation feasibility, specific functionality coverage, and program needs. Candidates must be able to plan and organize test cases and strategy, generate and review traceability to design requirements, and develop and review test specifications and test reports in compliance with design control procedures used within the medical device industry. Candidates must be willing to work and effectively prioritize multiple responsibilities in a fast-paced team environment.

CAS R&D seeks candidates who will meet our customer expectations by striving without reserve for the greatest possible reliability and quality in our products, processes, and systems by being accountable, having a voice, and taking action.

POSITION RESPONSIBILITIES

  • Support the design documentation and verification testing efforts for Windows-based computing systems software and embedded firmware systems, which are integrated with mechanical and electrical capital equipment.
  • Work in an evolving, maturing Agile environment as part of scrum team, in consultation with scrum masters, product owners, and other developers.
  • Investigate, propose, and implement new technologies, tools, or processes which improve the reliability and efficiency of software testing.
  • Train on and apply the appropriate standards, processes, procedures and tools throughout the software development life cycle, following FDA regulations as well as IEC 62304 for medical device software.
  • Effectively work with individuals from various engineering disciplines in a variety of locations, including supporting Manufacturing in troubleshooting operations through assembly and test.
  • Provide technical assistance to other functional departments such as Quality, Systems Engineering, Reliability, Service, and Manufacturing.
  • Support software deployment and release, supporting and troubleshooting DevOps components, continuous integration, and eventual manufacturing integration/installation and field release.
  • Maintain an attitude of positive flexibility, sometimes performing assigned work outside the boundaries of a typical software engineering job description to meet overall team deadlines and milestones.

BASIC QUALIFICATIONS/EDUCATION/EXPERIENCE

  • 3+ years of software development and/or test experience with bachelor’s degree in Computer Science, Software Engineering, Biomedical Engineering, Electrical Engineering, or other relevant engineering discipline; or 1+ years of experience with advanced degree.
  • 1+ years of experience in a regulated industry, including documentation activities such as technical specifications, requirements traceability, test procedures, and report writing. Able to organize, simplify, and concisely write about complex technical content.
  • 1+ years of experience writing requirements-driven tests in a regulatory environment.
  • Strong verbal and written communication skills.
  • Ability to mentor and review work of less experienced and/or remote engineering teams.
  • Ability to work in a multi-site team environment with strong collaboration skills. Ability to engage with technical and non-technical staff across multiple geographical R&D sites, including significant remote/videoconference-based work.

DESIRED/PREFERRED QUALIFICATIONS

  • 1+ years of experience using .NET/C#.
  • Experience in automated software testing in a Windows environment
  • Experience using Microsoft Visual Studio and Test Manager.
  • Experience developing test software and automation for capital equipment with C# language and .NET framework.
  • Experience with Graphical User Interface (GUI) testing
  • Experience with Team Foundation Server or Azure Devops.
  • Experience with security techniques and protocols.
  • Experience with medical devices or other regulated industries, cardiac ablation or electrophysiology products are a plus.
  • Specific knowledge of FDA software validation requirements and international medical device standards such as 62304.


Posted: October 18, 2021, 9:25 am
Category : Firmware Engineer
Job Type : Contract
Id : 8504
Region : Twin Cities

Looking for a Sr. Firmware Engineer to join a SW/FW Organization to design, develop, and document new designs and modifications to firmware for Medical Devices. The Sr. Firmware Engineer may also be responsible for designing or supporting automated test systems.

Areas of responsibilities may include firmware design, firmware requirements, implementation/coding, technical documentation, test requirements and test procedures, software simulation and test automation. Candidates must be able to translate design inputs into firmware options and concepts, write detailed firmware specifications, implement functionality within the firmware architecture using established design patterns and best practices, generate and review design documentation, interface specifications, test specifications and test reports in compliance with design control procedures used within the medical device industry. Candidates must be willing to work and effectively prioritize multiple responsibilities in a fast-paced team environment.

Cardiac Ablation Solutions seeks candidates who will meet our customer expectations by striving without reserve for the greatest possible reliability and quality in our products, processes and systems by being accountable, having a voice, and taking action.

POSITION RESPONSIBILITIES

  • Work in an evolving, maturing Agile environment as part of scrum team developing medical device firmware, in consultation with scrum masters, product owners, and senior developers.
  • Design, develop, test, document, operate, and maintain firmware components to be applied to and integrated with electromechanical systems.
  • Investigate, propose, and implement new technologies or processes which enhance product features, improve reliability, and/or lower cost.
  • Apply the appropriate standards, processes, procedures, and tools throughout the software development life cycle.
  • Effectively work with individuals from various engineering disciplines in a variety of locations, including supporting manufacturing operations in troubleshooting, assembly, and test.
  • Provide technical assistance to and work effectively with other functional departments such as Systems, Security, Quality, Reliability, and Manufacturing.

BASIC QUALIFICATIONS/EDUCATION/EXPERIENCE

  • 5+ years of firmware development experience with bachelor’s degree in Engineering (Electrical, Software, or Biomedical preferred), or 3+ years of experience with additional advanced degree.
  • Experience with embedded software development in C language.
  • Experience with basic laboratory instruments and tools (e.g. DMM, oscilloscope, protocol analyzer, logic analyzer, spectrum analyzer).
  • Ability to work in a multi-site team environment displaying strong collaboration skills.
  • Self-motivated and be able to work with minimal supervision.
  • Experience in technical specification and report writing.
  • Excellent written and oral communication skills, including the ability to summarize complex technical concepts and problems clearly and concisely.

DESIRED/PREFERRED QUALIFICATIONS

  • M.S. Software or Electrical Engineering
  • Experience in developing firmware using a Real Time Operating System.
  • Experience working with hardware, including ability to read schematics, data sheets and interface specifications.
  • Experience with medical devices or other regulated industries, cardiac ablation or electrophysiology products are a plus.
  • Specific knowledge of FDA software validation requirements and international medical device standards such as 62304.
  • Experience with software security development.
  • Experience with any of: ARM Cortex M processors (preferably STMicro), µC/OS-II real-time operating system, TCP/IP communication and lwIP, microcontroller communication protocols: SPI, I2C, RS232 and USB.
  • Experience with IAR Embedded Workbench and/or Unity unit test framework.


Posted: October 18, 2021, 8:46 am
Category : Quality/Regulatory
Job Type : Contract
Id : 8503
Region : Twin Cities

The Sr. Supplier Quality Engineer ensures that suppliers deliver quality parts, materials, and services. Qualifies suppliers according to company standards and may administer Supplier Owned Quality (SOQ) Program to ensure cost effectiveness. Monitors parts from acquisition through the manufacturing cycle and communicates and resolves supplier related problems as they occur. Evaluates suppliers' internal functions to assess their overall performance and provides feedback in assessment of their operation.

 

Responsibilities:

  • Provide Supplier Quality Engineering support to product development programs for new medical device product
  • Provide input to and align activities to development project schedule
  • Provide technical expertise during supplier evaluation and selection
  • Lead efforts to prepare external CM/OEM supplier's product from development through production release
  • Determine the required supplier process development/validation and qualification activities and partner with Supply Chain to communicate requirements to the suppliers
  • Ensure documentation is completed per quality system procedures for supplier process development/validation and product qualification
  • Establish controls (process, product, inspection) at the supplier through receipt at a high volume manufacturing facility based on risk input
  • Provide status updates as required per assigned projects
  • Apply QSR 21CFR Part 820 (Medical Devices) to everyday applications of Supplier Quality Engineering activities
  • Define, establish and implement supplier quality assurance processes for medical device product
  • Lead or participate in product, business process or quality system level improvement initiatives
  • Provide training and coaching to suppliers or Company personnel on Quality System Regulation, ISO and quality system requirements
  • Participate in internal and supplier audits
  • Travel as required to support assigned projects or other application work requirements. Typically  0 – 25%

 

Required Knowledge and Experience:

Requires advanced knowledge of job area combining breadth and depth, typically obtained through advanced education combined with experience. May have practical knowledge of project management. Requires a University Degree and minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience.



Posted: October 15, 2021, 7:26 am
Category : Quality Engineer - Medical Device
Job Type : Contract
Id : 8502
Region : Twin Cities

The Quality Engineer develops, modifies, applies and maintains quality standards and protocol for processing materials into partially finished or finished materials product. Collaborates with engineering and manufacturing functions to ensure quality standards are in place. Devises and implements methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment. Designs or specifies inspection and testing mechanisms and equipment; conducts quality assurance tests; and performs statistical analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards and specifications. Ensures that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements. May specialize in the areas of design, incoming material, production control, product evaluation and reliability, inventory control and/or research and development as they apply to product or process quality.

Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering and overseeing the projects from design to implementation while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education (typically University).

  • Autonomy: Seasoned individual contributor. Works independently under limited supervision to determine and develop approach to solutions. Coaches and reviews the work of lower level specialists; may manage projects / processes.
  • Organizational Impact: May be responsible for entire projects or processes within job area. Contributes to the completion of work group objectives, through building relationships and consensus to reach agreements on assignments.
  • Innovation and Complexity: Problems and issues faced are difficult, and may require understanding of multiple issues, job areas or specialties. Makes improvements of processes, systems or products to enhance performance of the job area. Analysis provided is in depth in nature and often provides recommendations on process improvements.
  • Communication and Influence: Communicates with senior internal and external customers and vendors. Exchange information of facts, statuses, ideas and issues to achieve objective, and influence decision making.
  • Leadership and Talent Management: May provide guidance, coaching and training to other employees within job area. May manage projects, requiring delegation of work and review of others' work product.
  • Required Knowledge and Experience: Requires advanced knowledge of job area combining breadth and depth, typically obtained through advanced education combined with experience. May have practical knowledge of project management. Requires a University Degree and minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience.


Posted: October 14, 2021, 9:29 am
Category : Manufacturing Engineer
Job Type : Contract
Id : 8501
Region : Twin Cities

Seeking a Sr. Manufacturing Engineer to be the primary lead for MDR remediation and validation for a major medical device company. Designs manufacturing processes, procedures and production layouts for assemblies, equipment installation, processing, machining and material handling. Designs arrangement of machines within plant facilities to ensure most efficient and productive layout. Designs sequence of operations and specifies procedures for the fabrication of tools and equipment and other functions that affect product performance. Adapts machine or equipment design to factory and production conditions. May incorporate inspection and test requirements into the production plan. Inspects performance of machinery, equipment, and tools to verify their efficiency, and investigates and initiates corrective action of problems and deficiencies to ensure product quality. Develops manufacturing processes that are applicable to statistical process control, and may develop those techniques. Provides guidance to engineering regarding design concepts and specification requirements to best utilize equipment and manufacturing techniques. Ensures processes and procedures are in compliance with regulations.

Position Requirements:

  • MDR Remediation experience
  • Validation Experience
  • Project Management skills
  • Bachelors degree with 4 years relevant experience


Posted: October 12, 2021, 1:44 pm
Category : Quality Engineer - Medical Device
Job Type : Contract
Id : 8499
Region : Twin Cities

The Quality Engineer develops, modifies, applies and maintains quality standards and protocol for processing materials into partially finished or finished materials product. Collaborates with engineering and manufacturing functions to ensure quality standards are in place. Devises and implements methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment. Designs or specifies inspection and testing mechanisms and equipment; conducts quality assurance tests; and performs statistical analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards and specifications. Ensures that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements. May specialize in the areas of design, incoming material, production control, product evaluation and reliability, inventory control and/or research and development as they apply to product or process quality.

Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering and overseeing the projects from design to implementation while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education (typically University).

  • Autonomy: Established and productive individual contributor. Works independently with general supervision on larger, moderately complex projects / assignments.
  • Organizational Impact: Sets objectives for own job area to meet the objectives of projects and assignments. Contributes to the completion of project milestones. May have some involvement in cross functional assignments.
  • Innovation and Complexity: Problems and issues faced are general, and may require understanding of broader set of issues or other job areas but typically are not complex. Makes adjustments or recommends enhancements in systems and processes to solve problems or improve effectiveness of job area.
  • Communication and Influence: Communicates primarily and frequently with internal contacts. External interactions are less complex or problem solving in nature. Contacts others to share information, status, needs and issues in order to inform, gain input, and support decision making.
  • Leadership and Talent Management: May provide guidance and assistance to entry level professionals and / or employee in Support Career Stream.
  • Required Knowledge and Experience: Requires practical knowledge and demonstrated competence within job area typically obtained through advanced education combined with experience. Requires a University Degree and minimum of 2 years of relevant experience, or advanced degree with 0 years of experience.


Posted: October 12, 2021, 8:47 am
Category : Sr. Applications Engineer
Job Type : Contract
Id : 8488
Region : Twin Cities

Seeking a Data Engineer to be part of a team that designs custom software solutions and builds foundational data analytics and integration platforms for R&D, process development and manufacturing needs.  Use your knowledge and passion for automation, manufacturing and medical devices to help shape the needs the medical device industry.

 

Purpose Statement:

Develops software and foundational platforms used in the development and production of medical devices.  Under limited supervision or as member of a team: directs, develops concepts and executes, designs, plans, and builds data analytics and manufacturing integration platforms.  Also provides support of existing applications in relevant environment(s); troubleshoots problems, execute requirements for upgrades and incremental enhancements.

 

Key Experience:

  • In depth knowledge of SQL Server: Transact SQL, Database design & programming, SSRS reporting, Data Transformation/ETL
  • Experience with database design, stored procedures, functions and/or views, implementation, maintenance (tuning, backup/restore), data migration (on-prem to cloud based SQL technology), SQL Server, PostGres/MySQL, Object/Relational Mapping, and data warehouses.
  • Experience with C#, Python, and/or Go
  • Knowledge of microservices, containerization (Kuberneters/Docker) and AWS
  • Experience with authentication and authorization using Active Directory (on-prem and Azure).
  • Experience with cloud platforms for support and development of solutions, transferring from on prem to cloud architecture models
  • Ensure product robustness through unit tests and other quality control measures

 

Nice to have:

  • Knowledge of working with manufacturing data, MES, PLC
  • Expertise in Full Stack Web Application development


Posted: October 11, 2021, 2:16 pm
Category : Manufacturing Engineer
Job Type : Contract
Id : 8498
Region : Twin Cities

The Manufacturing Engineer designs manufacturing processes, procedures and production layouts for assemblies, equipment installation, processing, machining and material handling. Designs arrangement of machines within plant facilities to ensure most efficient and productive layout. Designs sequence of operations and specifies procedures for the fabrication of tools and equipment and other functions that affect product performance. Adapts machine or equipment design to factory and production conditions. May incorporate inspection and test requirements into the production plan. Inspects performance of machinery, equipment, and tools to verify their efficiency, and investigates and initiates corrective action of problems and deficiencies to ensure product quality. Develops manufacturing processes that are applicable to statistical process control, and may develop those techniques. Provides guidance to engineering regarding design concepts and specification requirements to best utilize equipment and manufacturing techniques. Ensures processes and procedures are in compliance with regulations.

Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering and overseeing the projects from design to implementation while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education (typically University).

  • Autonomy: Established and productive individual contributor. Works independently with general supervision on larger, moderately complex projects / assignments.
  • Organizational Impact: Sets objectives for own job area to meet the objectives of projects and assignments. Contributes to the completion of project milestones. May have some involvement in cross functional assignments.
  • Innovation and Complexity: Problems and issues faced are general, and may require understanding of broader set of issues or other job areas but typically are not complex. Makes adjustments or recommends enhancements in systems and processes to solve problems or improve effectiveness of job area.
  • Communication and Influence: Communicates primarily and frequently with internal contacts. External interactions are less complex or problem solving in nature. Contacts others to share information, status, needs and issues in order to inform, gain input, and support decision making.
  • Leadership and Talent Management: May provide guidance and assistance to entry level professionals and / or employee in Support Career Stream.
  • Required Knowledge and Experience: Requires practical knowledge and demonstrated competence within job area typically obtained through advanced education combined with experience. Requires a University Degree and minimum of 2 years of relevant experience, or advanced degree with 0 years of experience.


Posted: October 11, 2021, 1:14 pm
Category : Manufacturing Engineer
Job Type : Contract
Id : 8497
Region : Twin Cities

The Senior Manufacturing Engineer designs manufacturing processes, procedures and production layouts for assemblies, equipment installation, processing, machining and material handling. Designs arrangement of machines within plant facilities to ensure most efficient and productive layout. Designs sequence of operations and specifies procedures for the fabrication of tools and equipment and other functions that affect product performance. Adapts machine or equipment design to factory and production conditions. May incorporate inspection and test requirements into the production plan. Inspects performance of machinery, equipment, and tools to verify their efficiency, and investigates and initiates corrective action of problems and deficiencies to ensure product quality. Develops manufacturing processes that are applicable to statistical process control, and may develop those techniques. Provides guidance to engineering regarding design concepts and specification requirements to best utilize equipment and manufacturing techniques. Ensures processes and procedures are in compliance with regulations.

Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering and overseeing the projects from design to implementation while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education (typically University).

  • Autonomy: Seasoned individual contributor. Works independently under limited supervision to determine and develop approach to solutions. Coaches and reviews the work of lower level specialists; may manage projects / processes.
  • Organizational Impact: May be responsible for entire projects or processes within job area. Contributes to the completion of work group objectives, through building relationships and consensus to reach agreements on assignments.
  • Innovation and Complexity: Problems and issues faced are difficult, and may require understanding of multiple issues, job areas or specialties. Makes improvements of processes, systems or products to enhance performance of the job area. Analysis provided is in-depth in nature and often provides recommendations on process improvements.
  • Communication and Influence: Communicates with senior internal and external customers and vendors. Exchange information of facts, statuses, ideas and issues to achieve objective, and influence decision making.
  • Leadership and Talent Management: May provide guidance, coaching and training to other employees within job area. May manage projects, requiring delegation of work and review of others' work product.
  • Required Knowledge and Experience: Requires advanced knowledge of job area combining breadth and depth, typically obtained through advanced education combined with experience. May have practical knowledge of project management. Requires a University Degree and minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience.


Posted: October 11, 2021, 6:57 am
Category : Quality Engineer - Medical Device
Job Type : Contract
Id : 8496
Region : Twin Cities

Seeking a Senior Design Quality Engineer to work with cross-functional teams to support new product development for a major medical device company. An understanding of product development, mechanical design, validation, and/or design for reliability/six sigma is preferred. As an important member of our Quality Team, you will provide guidance and implement strategies that drive product quality and continuous improvement.

POSITION RESPONSIBILITIES MAY INCLUDE THE FOLLOWING AND OTHER DUTIES MAY BE ASSIGNED:

  • Actively participate in product development cycle by reviewing project documentation, participating in product risk assessments, and working closely with the Product Development Team to develop appropriate verification and validation testing requirements.
  • Assesses overall product risk by facilitating the development of risk management tools such as the risk management report, failure mode and effects analyses (FMEAs), etc.
  • Collect, analyze and interpret statistical data. Performs analyses and provide reports to management as required.
  • Contributes to the successful completion of Process Validation initiatives by facilitating validation master plans and the qualification activities required to meet validation requirements. May include Process Flows, Control Plans, Design of Experiments, Measurement Systems Analyses, and Process Capability Analyses.
  • Job requires interaction with cross-functional project team members as well as members of the QA extended team.
  • Tracking timelines and facilitating the required Quality Engineering deliverables.
  • Assisting with projects and assuring proper and consistent implementation of the quality engineering tools.
  • Provide support to other quality groups to assure efficient completion of project requirements.
  • Provide solutions to a wide range of difficult challenges. Work independently to determine and develop solutions that are imaginative, thorough, practicable, and consistent with organizational objectives.
  • Provide guidance on the principles of risk management standards as they relate to the new product development activities of mechanical medical devices

BASIC QUALIFICATIONS:

  • B.S. degree in Engineering, Math, Physical Science, or equivalent field
  • Preferred: M.S. degree in Engineering, Math, Physical Science, or equivalent field
  • Minimum Experience: 5+ years of experience in a regulated industry (2 years of experience can be substituted for an Advanced degree in a related discipline)
  • Fundamental understanding of mechanical designs and manufacturing processes to support designing, troubleshooting, refining and qualifying the design to ensure the sustainable manufacturing of medical devices both internal and external.
  • Experience in a regulated industry
  • EU MDR
  • Experience with Minitab or similar statistical analysis tools
  • Good interpersonal skills; Ability to work effectively in a team environment and build strong working relationships.
  • Ability to work in a fast-paced environment; Ability to work well under pressure and maintain positive, enthusiastic attitude
  • Strong attention to detail and accuracy. Ability to successfully balance and prioritize multiple ongoing projects/tasks (Project Management skills).
  • High degree of initiative and self-motivation. Strong analytical skills and the ability to solve problems through analytical reasoning.

NICE TO HAVE

  • ASQ Certified Quality Engineering (CQE)
  • Knowledge of and experience in developing and manufacturing medical devices in conformance with Quality System Regulations, ISO13485, 14971 and 60601 requirements
  • Experience with Geometric Dimensional and Tolorancing (GD&T) and the ability to read blueprints
  • Support reliability activities for new product development. Drive for root cause understanding and corrective action implementation to ensure product meets reliability requirements.


Posted: October 11, 2021, 6:26 am
Category : Quality Engineer - Medical Device
Job Type : Contract
Id : 8495
Region : Twin Cities

The Quality Engineer develops, modifies, applies and maintains quality standards and protocol for processing materials into partially finished or finished materials product. Collaborates with engineering and manufacturing functions to ensure quality standards are in place. Devises and implements methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment. Designs or specifies inspection and testing mechanisms and equipment; conducts quality assurance tests; and performs statistical analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards and specifications. Ensures that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements. May specialize in the areas of design, incoming material, production control, product evaluation and reliability, inventory control and/or research and development as they apply to product or process quality.

Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering and overseeing the projects from design to implementation while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education (typically University).

  • Autonomy: Established and productive individual contributor. Works independently with general supervision on larger, moderately complex projects / assignments. Organizational Impact: Sets objectives for own job area to meet the objectives of projects and assignments. Contributes to the completion of project milestones. May have some involvement in cross functional assignments.
  • Innovation and Complexity: Problems and issues faced are general, and may require understanding of broader set of issues or other job areas but typically are not complex. Makes adjustments or recommends enhancements in systems and processes to solve problems or improve effectiveness of job area.
  • Communication and Influence: Communicates primarily and frequently with internal contacts. External interactions are less complex or problem solving in nature. Contacts others to share information, status, needs and issues in order to inform, gain input, and support decision-making.
  • Leadership and Talent Management: May provide guidance and assistance to entry level professionals and / or employee in Support Career Stream.
  • Required Knowledge and Experience: Requires practical knowledge and demonstrated competence within job area typically obtained through advanced education combined with experience. Requires a University Degree and minimum of 2 years of relevant experience, or advanced degree with 0 years of experience.


Posted: October 11, 2021, 6:11 am
Category : Project Manager
Job Type : Contract
Id : 8494
Region : Twin Cities

The Engineering Project Manager plans, directs and implements all aspects of released product engineering for medical device products or software systems. May develop, evaluate, implement and maintain technical quality assurance and control systems or reliability systems and standards pertaining to materials, techniques, or company products. Oversees the investigation and evaluation of existing technologies. May guide the conceptualization of new methodologies, materials, machines, processes or products. Organizes the coordination of activities with outside suppliers and consultants to ensure timely delivery. Selects, develops and evaluates personnel to ensure the efficient operation of the function. Provides tactical and / or operational leadership and coaching. Receives assignments in task and objective oriented terms.

  • Organizational Impact: Establishes project plans and executes to those plans. Decisions impact program schedules, customer satisfaction levels, or allocation of time, material resources, expenditures and funds. May have budget or P&L accountability for projects. Strive for continuous improvement and consistency in deliverables.
  • Innovation and Complexity: Proposes modifications to functional operating policies and day-to-day processes. Problems and issues faced are complex, difficult and undefined, and require detailed information gathering, analysis and investigation to understand the problem.
  • Communication and Influence: Communicates with internal and external customers and vendors regarding project needs and updates. Uses information exchange, influence and active persuasion without direct exercise of command to gain cooperation of other parties . May interact on issues that have externally shared objectives.
  • Leadership and Talent Management: Manages core teams consisting of cross functional professionals in the Specialist career stream. Leads, directs and reviews the work of a team who exercise latitude and independence in their assignments.
  • Required Knowledge and Experience: Requires practical knowledge in leading and managing the execution of processes, projects and tactics within one job area. Typically has advanced knowledge and skills within catheter and capital system development and manufacturing with understanding of the impact of work on other areas of the organization. Requires a University Degree and minimum of 5 years relevant experience, or advanced degree with a minimum of 3 years prior relevant experience.


Posted: October 7, 2021, 6:53 am
Category : Mechanical Engineer
Job Type : Contract
Id : 8493
Region : Twin Cities

The Sr. Mechanical Design Engineer researches, plans, designs, verifies, validates and develops mechanical and/or electromechanical products and systems, such as metals, instruments, controls, plastics, robots, engines, machines and mechanical, resonance, hydraulic or heat transfer systems for production, transmission, measurement, and use of energy. Recommends various technology options or approaches for system, processes, facility or program improvements in terms of safety, performance, efficiency or costs. May be responsible for the transfer from R&D to manufacturing.

Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering and overseeing the projects from design to implementation while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education (typically University).

  • Autonomy: Seasoned individual contributor. Works independently under limited supervision to determine and develop approach to solutions. Coaches and reviews the work of lower level specialists; may manage projects / processes.
  • Organizational Impact: May be responsible for entire projects or processes within job area. Contributes to the completion of work group objectives, through building relationships and consensus to reach agreements on assignments.
  • Innovation and Complexity: Problems and issues faced are difficult, and may require understanding of multiple issues, job areas or specialties . Makes improvements of processes, systems or products to enhance performance of the job area. Analysis provided is in depth in nature and often provides recommendations on process improvements.
  • Communication and Influence: Communicates with senior internal and external customers and vendors. Exchange information of facts, statuses, ideas and issues to achieve objective, and influence decision making.
  • Leadership and Talent Management: May provide guidance, coaching and training to other employees within job area. May manage projects, requiring delegation of work and review of others' work product .
  • Required Knowledge and Experience: Requires advanced knowledge of job area combining breadth and depth, typically obtained through advanced education combined with experience. May have practical knowledge of project management. Requires a University Degree and minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience.


Posted: October 7, 2021, 6:30 am
Category : Electrical Engineer
Job Type : Contract
Id : 8492
Region : Twin Cities

The Sr. Electrical Engineer researches, develops, designs, and tests electrical components, equipment, systems, and networks. Designs electrical equipment, facilities, components, products, and systems for commercial, industrial, and domestic purposes.

Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering and overseeing the projects from design to implementation while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education (typically University).

  • Autonomy: Seasoned individual contributor. Works independently under limited supervision to determine and develop approach to solutions. Coaches and reviews the work of lower level specialists; may manage projects / processes.
  • Organizational Impact: May be responsible for entire projects or processes within job area. Contributes to the completion of work group objectives, through building relationships and consensus to reach agreements on assignments.
  • Innovation and Complexity: Problems and issues faced are difficult, and may require understanding of multiple issues, job areas or specialties . Makes improvements of processes, systems or products to enhance performance of the job area. Analysis provided is in depth in nature and often provides recommendations on process improvements.
  • Communication and Influence: Communicates with senior internal and external customers and vendors. Exchange information of facts, statuses, ideas and issues to achieve objective, and influence decision making.
  • Leadership and Talent Management: May provide guidance, coaching and training to other employees within job area. May manage projects, requiring delegation of work and review of others' work product .
  • Required Knowledge and Experience: Requires advanced knowledge of job area combining breadth and depth, typically obtained through advanced education combined with experience. May have practical knowledge of project management. Requires a University Degree and minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience.


Posted: October 7, 2021, 6:24 am
Category : Quality Engineer - Medical Device
Job Type : Contract
Id : 8490
Region : Twin Cities

Seeking a Sr. Supplier Quality Engineer to work closely with wider supplier quality and operation teams to drive continuous improvement and robust corrective/preventative actions through problem solving techniques at supplier to prevent recurrence of issues, and ultimately deliver high-quality products to customers for a major medical device company.

POSITION RESPONSIBILITIES:

  • Qualifies suppliers according to company standards and may administer a Certified Supplier Program in receiving inspection to ensure cost effectiveness
  • Ensures that suppliers deliver quality parts, materials, and services.
  • Delivering cost-down projects linked directly to Company suppliers
  • Communicate with management and project teams on a regular basis on supplier performance
  • Lead issue resolution of complex problems as they relate to supplied components and materials.
  • Develops and prioritizes an auditing schedule to ensure that designated suppliers are audited on a regular basis to ensure good manufacturing practices (GMP) and quality standards are met
  • Lead and provide technical assistance to suppliers/other resources performing qualification/validation testing. Ensure the resolution of all issues raised during testing/qualification.
  • Work with supplier and sub-tier suppliers, as required, to lead and drive systematic approaches and ensure stability related to medical device quality.
  • Develop strong partnerships with cross functional groups and provide quality leadership within these groups
  • Support in the review of supplier introduction and changes, coordinating activities with suppliers and with internal cross-functional support teams to develop and implement appropriate strategies to qualify and support
  • Ensure appropriate controls are in place at supplier, based on risk associated with product or service
  • Develop and drive technical direction input to component qualification strategies and documentation in conjunction with project teams to ensure high standards are in place
  • Define Receiving Inspection requirements as required and associated test method validation for all internal Company Test Methods.
  • Ensures that suppliers deliver quality parts, materials, and services. Qualifies suppliers according to company standards and may administer a Certified Supplier Program in receiving inspection to ensure cost effectiveness.
  • Monitors parts from acquisition through the manufacturing cycle and communicates and resolves supplier related problems as they occur.
  • Develops and prioritizes an auditing schedule to ensure that designated suppliers are audited on a regular basis to ensure good manufacturing practices (GMP) and quality standards are met.
  • Evaluates suppliers' internal functions to assess their overall performance and provides feedback in assessment of their operation.

POSITION REQUIREMENTS:

  • Qualified to Minimum of a University Bachelors degree in a relevant technical discipline (e.g. Engineering, Science or technical field)
  • Minimum of 4 years relevant experience, or less with an advanced degree
  • A dynamic team player, can work effectively and proactively on cross-functional teams with good communication and technical writing skills
  • Previous experience in Supplier Quality an advantage.


Posted: October 5, 2021, 10:27 am
Category : Quality/Regulatory
Job Type : Contract
Id : 8487
Region : Twin Cities

We are seeking an experienced engineer to join our Structural Heart Development Quality team. The individual in this position will assure new or modified products conform to requirements and establish compliance with the quality system. This position is responsible for maintaining a strong collaborative partnership with cross-functional team members that facilitates organizational success by protecting patient/user safety and meeting business needs. This position will support new product development projects and lead completion of design control deliverables, such as design verification, design validation and risk management.

Primary Duties and Responsibilities:

  • Participate in or lead teams in supporting quality disciplines, decisions, and practices (e.g., represent the Quality function as a Core Team Member)
  • Lead on-time completion of Design Control Deliverables
  • Create and ensure on-time execution of Quality Plans for internal development, OEM-based, Clinical
  • Product Development (CPDP), and design change projects
  • Accountable for Design Verification and Validation planning and execution, including active cross-functional root-cause analysis investigation and resolution activities
  • Lead or support Risk Management activities, including analyzing field data to support new product development, supporting Failure Mode Effects Analysis, generation of risk management plans/reports, and completion of hazard analysis
  • Support design test and inspection method development, and lead method validation activities
  • Ensure Device History File (DHF) content completion, integrity, and regulatory & standards compliance; collaboratively identifying, communicating and resolving gaps
  • Support manufacturing process development and qualification for new product commercialization and product changes
  • Support internal and external audit responses and on-time product re-certifications
  • Support and ensure the establishment of objective, measurable, discrete, and verifiable customer and product requirements
  • Support and ensure objective component specification definitions, supplied component sampling plan development, and vendor qualifications
  • Support the development and review of biocompatibility and sterilization validations
  • Supports R&D product builds for bench testing, animal lab, and first in human activities.
  • Complete Document Change Request Reviews in a timely and objective manner
  • Participates in Corrective Action/Preventive Action (CAPA) process including the investigation of failures or deviations, as required.
  • Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues
  • Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements,
  • Company policies, operating procedures, processes, and task assignments
  • Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors
  • Additional duties may be identified by functional management based on the current project/business objectives.
  • Support all Divisional initiatives as identified by divisional management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements

Required Qualifications:

  • Bachelor’s degree within an Engineering field or related science-based discipline
  • 2-5 years of related work experience
  • Previous Quality engineering experience and demonstrated use of Quality tools/methodologies
  • Solid verbal, written, and interpersonal skills with ability to effectively communicate at multiple levels in the organization
  • Ability to work in a highly matrixed and geographically diverse business environment.
  • Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
  • Ability to leverage and/or engage others to accomplish projects.
  • Multitasks, prioritizes and meets deadlines in timely manner.
  • Strong organizational and follow-up skills, as well as attention to detail.
  • Ability to travel approximately 10%, including internationally.

Preferred Qualifications:

  • Advanced degree in a technical field
  • Medical device experience, specifically with valves and /or implantable devices
  • Experience working in a broader enterprise/cross-division business unit model
  • Prior experience working with any or all of the following:
  • ISO 13485 Medical Devices – Quality Management System
  • 21 CFR Part 820 FDA Quality System Regulations
  • ISO 14971 Medical Devices – Application of Risk Management
  • EUMDR
  • MDSAP
  • Good Manufacturing Practices And Good Documentation Practices


Posted: October 1, 2021, 9:09 am
Category : Systems Engineer
Job Type : Contract
Id : 8486
Region : Twin Cities

The Principal Systems Engineer performs technical planning, system integration, verification and validation, evaluates alternatives including cost and risk, supportability and analyses for total systems. Analyses are performed at all levels of total system product to include: concept, design, fabrication, test, installation, operation, maintenance and disposal. Ensures the logical and systematic conversion of product requirements into total systems solutions that acknowledge technical, schedule, and cost constraints. Performs functional analysis, timeline analysis, detail trade studies, requirements allocation and interface definition studies to translate customer requirements into hardware and software specifications.

Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering and overseeing the projects from design to implementation while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education (typically University).

  • Autonomy: Recognized expert, managing large projects or processes. Exercises considerable latitude in determining deliverables of assignments, with limited oversight from manager. Coaches, reviews and delegates work to lower level specialists.
  • Organizational Impact: Contributes to defining the direction for new products, processes, standards, or operational plans based on business strategy with a significant impact on work group results. May manage large projects or processes that span outside of immediate job area.
  • Innovation and Complexity: Problems and issues faced are difficult, moderately complex and undefined, and require detailed information gathering, analysis and investigation. Develops solutions to moderately complex problems, and/or makes moderate to significant improvements of processes, systems or products independently to enhance performance of job area. Implements solutions to problems.
  • Communication and Influence: Represents organization as a primary contact for specific projects and initiatives; communicates with internal and external customers and vendors at various levels. May negotiate with others to reach understanding or agreement, and influence decision making.
  • Leadership and Talent Management: Typically provides guidance, coaching and training to other employees within job area. Typically manages major / moderately complex projects, involving delegation of work and review of work products, at times acting as a team leader.
  • Required Knowledge and Experience: Requires mastery of a specialty area and full knowledge of industry practices, typically obtained through advanced education combined with experience. May have broad knowledge of project management. Requires a University Degree and minimum 7 years of relevant experience, or advanced degree with a minimum of 5 years of relevant experience.


Posted: October 1, 2021, 7:13 am
Category : Test Engr - Technical
Job Type : Contract
Id : 8485
Region : Twin Cities

We are seeking an experienced Sr. Test Engineer to support our manufacturing process development group. This role is focused on the design and development of software and hardware to test new products.

  • Develops Automatic Test Equipment (ATE) used in manufacturing to verify that Company products are fully functional and free of manufacturing-related defects.
  • Assists others in the design and development of interface hardware, fixtures and circuit boards to test medical capital equipment.
  • Updates existing test software to support updates in product designs. Updates all test system documentation to support changes.
  • Uses engineering background to identify and resolve discrepancies between new design test requirements and test system capabilities.
  • Coordinates deployment of test software and hardware to manufacturing and provides follow-up support to facilitate resolution of problems.
  • Investigates and resolves production problems involving manufacturing test equipment software and hardware
  • Complies with all U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.
  • Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
  • Performs other related duties as assigned.

Your experience(s), education and knowledge includes:

  • Bachelor of Science in electrical engineering or related engineering field.
  • Minimum of eight years’ experience in electrical test and test equipment design/development.
  • Minimum of five years of experience programming in National Instruments’ LabVIEW (CLAD and CLD certifications are desirable).
  • Experience with developing test sequences using National Instruments’ TestStand is desirable.
  • Familiarity with Python programming language.
  • Broad familiarity or experience with Automatic Test Equipment (ATE) systems.
  • Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
  • Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
  • Multitasks, prioritizes and meets deadlines in timely manner.
  • Strong organizational and follow-up skills, as well as attention to detail.


Posted: September 30, 2021, 9:46 am
Category : Quality Engineer - Medical Device
Job Type : Contract
Id : 8484
Region : Twin Cities

Seeking a Supplier Quality Engineering to be responsible for the quality of materials and services provided by external suppliers. You will contribute as a team member the EU MDR Remediation key strategic initiative.

Responsibilities may include the following and other duties may be assigned.

  • Drive completion of Technical Documentation remediation related activities.
  • Partner cross-functionally to determine quality impact of supplied components/services.
  • Collaborate with the EU MDR team to ensure deliverables are completed on-time.
  • Provide guidance on direction of EU MDR Supplier Quality deliverables and best way to achieve those deliverables.
  • Assist in developing Supplier Quality Agreements with key suppliers including coordinating negotiations and processing through cross functional approval (Including Legal, Quality and Sourcing Support projects/programs associated with component(s) qualification (Independent reviewer and approver)
  • Review Drawings configuration, mechanical interfaces/operation and material selection to determine the appropriate inspection requirements, methods and sample sizes
  • Review/Approve test plans and reports (qualification, validation) for assigned change and new tool development activities.
  • Develop a strong relationship with supplier as related to quality system issues
  • Develop and maintain strong working relationship with functional groups (R&D, ME, Quality Operations, Supply Chain and Regulatory)
  • Assure the resolution of all issues raised during processing and inspection/testing with supplier.
  • Provide support to sustaining engineering.
  • Provide input into the design, reliability, and manufacturability of new products and coordinate activities within our supplier base. Work closely with component engineers to ensure supplier practices are used across the business.
  • Provide statistical support by the creation of supplier related metrics for the purposes of tracking processing performance and identifying opportunities for supplier improvements.
  • Work with the Quality Management System and maintain compliance with corporate policies, FDA’s QSRs, ISO 9001, IVDD, AIMDD, CMDCAS, CMDR, ISO 13485, MDD/EN46001 and other quality requirements, regulations and guidelines.
  • Use and understand of Statistical Tools (Design of Experiments, Measurement System Analysis, Process Capability and Statistical Process Control)
  • Have expert level knowledgeable of the processes characterization studies and creation of qualification protocols and reports (including structured DOE evaluation and/or IQ/OQ/PQ/PV documentation)
  • Understand Geometric Dimensional Tolerancing (GDT) and apply for inspection setup and tolerancing allowances of molded components

Must Have: Minimum Requirements

  • Bachelor’s degree in Engineering or Science field
  • 0+ years of experience in an engineering role or in the medical device industry

Nice to Haves:

  • Experience working in Medical Device or other highly regulated industry preferred
  • Oral, Presentation and Written communication skills
  • Work in a team/partnership environment
  • Computer Skills (Microsoft- Word, Excel, Project, PowerPoint)
  • Solid understanding of technical principles i.e., risk management, supplier audits, corrective/preventive action, control plans and test method validation
  • Knowledge of applicable GMP, FDA and ISO regulations
  • Practical working knowledge of statistical data analysis and quality improvement tools and techniques


Posted: September 30, 2021, 8:33 am
Category : Quality Engineer - Medical Device
Job Type : Contract
Id : 8483
Region : Twin Cities

The Quality Engineer develops, modifies, applies and maintains quality standards and protocol for processing materials into partially finished or finished materials product for a major medical device company.

  • Collaborates with engineering and manufacturing functions to ensure quality standards are in place.
  • Devises and implements methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment.
  • Designs or specifies inspection and testing mechanisms and equipment; conducts quality assurance tests; and performs statistical analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards and specifications.
  • Ensures that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements.
  • May specialize in the areas of design, incoming material, production control, product evaluation and reliability, inventory control and/or research and development as they apply to product or process quality.
  • Responsible for site transfer of capital equipment servicing procedures, fixtures, tools, and knowledge.
  • Strategize and create procedures, quality documents, service manuals, or other documentation required for depot service teams.
  • Performs design validation and other validation/verification activities.
  • Responsible for risk management
  • Familiar with Medical Device standards

Required Knowledge and Experience:

  • Requires a University Degree and minimum of 2 years of relevant experience, or advanced degree with 0 years of experience.


Posted: September 29, 2021, 9:40 am
Category : Software Engineering
Job Type : Contract
Id : 8482
Region : Twin Cities

Seeking a Validation Engineer to ensure the quality of software applications and equipment by validating/qualifying to specifications. This position will provide comprehensive documentation (specifications and validation/qualifications) per the division's policy to meet FDA regulations.

Position Responsibilities Include:

  • Define the development of comprehensive specifications (hardware and/or software) for equipment/software from basic functionality to complex systems such as PLC's, Visual Basic applications, databases, SCADA applications, and systems with FDA defined electronic records and electronic signatures.
  • Provide project estimates independently. Review estimates for Engineer I's.
  • Submit specification, protocol and report for approvals and documentation control via a Change Request.
  • Develop comprehensive software validations and/or equipment qualification protocols per the specification.
  • Execute software validation and/or qualification protocols & record results.
  • Document communicate and follow-up on software/equipment issues.
  • Complete project deliverables per project schedule and monitor project schedule and scope changes to assure team can meet delivery requirements.
  • Create documents, links and Change Requests utilizing a Product Data Management system.
  • Provide information on FDA/QSR regulations and internal process validation policy with regards to software validations, equipment installation qualifications, electronic records & signatures.
  • Develop and review comprehensive validation procedures in compliance with FDA.
  • Perform project lead activities on small to large-scale validation/qualification projects. Participate in vendor evaluations.
  • Provide guidance, mentoring and training to Engineer I's & II's. Ensure consistency of work among Engineer I's & II's. Provide peer reviews on specifications, protocols and reports.
  • Influences and defines functional, departmental and divisional policies & procedures through involvement with cross-functional engineering initiatives.
  • Provide leadership role on championing functional best practices.

Minimum Qualifications:

  • Bachelor’s Degree in Engineering Discipline
  • 5-9 years direct experience
  • Experience in Medical Device manufacturing specifically writing compliance documentation
  • In depth knowledge of MS Office tools
  • Must have excellent organization, clear verbal and written skills
  • Experience working in a SDLC-system development lifecycle
  • Hand on skills using navigating equipment user interfaces
  • High level attention to detail and ability to support multiple priorities at once
  • Must be team-oriented with people skills and positive can-do attitude in dealing with many customers, from various departments (Engineering, R&D, Manufacturing, Regulatory, etc.)

Preferred Qualifications:

  • Experience working in FDA-regulated industry
  • Experience working with a regulatory body in an audit
  • Performed in a quality role ensuring industry compliance
  • Practical knowledge of 21 CFR Part 11 (electronic records/electronic signature)


Posted: September 28, 2021, 8:31 am
Category : R&D Engineer
Job Type : Contract
Id : 8481
Region : Twin Cities

Seeking a Sr. R&D Engineer to be a part of the EU-MDR program, supporting the Development team with Tech file remediation activities for a major medical device company.

Essential Functions:

  • Collaborate, review, and route requirements, specifications, test protocols, test results, and maintain a robust Design History File (DHF).
  • Ensure and comply with all applicable regulations, standards, best practices and Company procedures.
  • Participate with cross-functional teams to review and prioritize requirements and to develop concise, unambiguous, non-conflicting and feasible product requirements that support market needs.
  • Participate in technical reviews, design reviews, Change Control Board (CCB) reviews, and take actions to closure.
  • Generate documentation at the project level, including R&D checklists, R&D Technical sections and answer queries from Regulatory team on Technical Documentation.
  • Oversee testing and analysis for product requirements compliance.

Must Have Requirements:

  • Bachelor’s degree in Engineering or Science field with minimum 5+ years of work experience in Design Quality Assurance
  • Strong familiarity with ISO 13485, 21 CFR 820, ISO 14971, EU MDD/MDR, EN ISO 60601-1
  • Excellent troubleshooting and investigation skills including test protocol/ report development and technical writing.
  • Experience in Design Verification and Validation, DHF and Technical Files for conformance to applicable regulation.

Nice to Have Qualification:

  • Familiarity with Agile Document Management System
  • Exposure to blood management / perfusion products


Posted: September 27, 2021, 10:46 am
Category : Manufacturing Engineer
Job Type : Contract
Id : 8478
Region : Twin Cities

Seeking a Process Development Engineer who applies engineering principles and ingenuity to design and develop manufacturing processes, technologies, tooling, and fixturing for next generation medical devices.

  • Design Support - Establish processes based on product and print requirements. Evaluate process and design alternatives based on Design for Manufacturability principles.
  • Process Optimization - Design and qualify equipment, fixtures, and tooling in order to understand process input and output relations via technical reports and Test Method Validations (TMV).
  • Process Validation - Protocol and report writing, as well as execution of IQ/OQ/PQs, and PPQs.
  • Root Cause Analysis and Troubleshooting - Resolves and/or facilitates the resolution of problems including identifying causes and implementing solutions to prevent re-occurrence.
  • Risk Management - Perform risk management activities using Failure Mode and Effect Analysis methodology (e.g. dFMEA, pFMEA).
  • Production support - Provide technical support for manufacturing processes and equipment to ensure high quality and yield.
  • Lead and interact with functional groups (e.g. research and development, quality, manufacturing, supply chain) as necessary to define work breakdown to achieve project goals related to schedule, performance, and cost.
  • Plan and conduct small to medium size projects. Coordinates and monitors activities. Makes judgments regarding quality of implementation within discipline.
  • Manage program compliance with internal and external standards (e.g. Design Control, Process Validation, and Process Control Plans).
  • Understand work environment issues (e.g. OSHA regulations, etc.).

EDUCATION AND EXPERIENCE

Required

  • Bachelor of Science in Engineering
  • 3-5 years engineering experience
  • prior medical device experience preferred.

Preferred

  • Experience developing manufacturing processes, technologies, and Design for Manufacturability (DFM).
  • Experience with statistical analysis (e.g. Gage R&R, Cpk, SPC, DOE), Six Sigma certification and Minitab experience preferred.


Posted: September 24, 2021, 12:43 pm
Category : Quality/Regulatory
Job Type : Contract
Id : 8477
Region : Twin Cities

The Supplier Quality Engineer ensures that suppliers deliver quality parts, materials, and services. Qualifies suppliers according to company standards and may administer a Certified Supplier Program in receiving inspection to ensure cost effectiveness. Monitors parts from acquisition through the manufacturing cycle and communicates and resolves supplier related problems as they occur. Develops and prioritizes an auditing schedule to ensure that designated suppliers are audited on a regular basis to ensure good manufacturing practices (GMP) and quality standards are met. Evaluates suppliers' internal functions to assess their overall performance and provides feedback in assessment of their operation.

Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering and overseeing the projects from design to implementation while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education (typically University).

  • Autonomy: Established and productive individual contributor. Works independently with general supervision on larger, moderately complex projects / assignments.
  • Organizational Impact: Sets objectives for own job area to meet the objectives of projects and assignments. Contributes to the completion of project milestones. May have some involvement in cross functional assignments.
  • Innovation and Complexity: Problems and issues faced are general, and may require understanding of broader set of issues or other job areas but typically are not complex. Makes adjustments or recommends enhancements in systems and processes to solve problems or improve effectiveness of job area.
  • Communication and Influence: Communicates primarily and frequently with internal contacts. External interactions are less complex or problem solving in nature. Contacts others to share information, status, needs and issues in order to inform, gain input, and support decision making.
  • Leadership and Talent Management: May provide guidance and assistance to entry level professionals and / or employee in Support Career Stream. Required Knowledge and Experience:
  • Requires practical knowledge and demonstrated competence within job area typically obtained through advanced education combined with experience. Requires a University Degree and minimum of 2 years of relevant experience, or advanced degree with 0 years of experience.


Posted: September 24, 2021, 12:32 pm
Category : Reliability Engineer
Job Type : Contract
Id : 8473
Region : Twin Cities

The Sr. Software Reliability Engineer develops, coordinates and conducts technical reliability studies and evaluations of engineering design concepts and design of experiments (DOE) constructs. Recommends design or test methods and statistical process control procedures for achieving required levels of product reliability. Completes risk analysis studies of new design and processes. Compiles and analyzes performance reports and process control statistics; investigates and analyzes relevant variables potentially affecting product and processes. Ensures that corrective measures meet acceptable reliability standards. Analyzes preliminary plans and develops reliability engineering programs to achieve company, customer and governmental agency reliability objectives. May develop mathematical models to identify units, batches or processes posing excessive failure risks. As necessary, proposes changes in design or formulation to improve system and/or process reliability. May determine units and/or batches requiring environmental testing, and specifies minimum number of samples to obtain statistically valid data.

Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering and overseeing the projects from design to implementation while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education (typically University).

  • Autonomy: Seasoned individual contributor. Works independently under limited supervision to determine and develop approach to solutions. Coaches and reviews the work of lower level specialists; may manage projects / processes.
  • Organizational Impact: May be responsible for entire projects or processes within job area. Contributes to the completion of work group objectives, through building relationships and consensus to reach agreements on assignments.
  • Innovation and Complexity: Problems and issues faced are difficult, and may require understanding of multiple issues, job areas or specialties. Makes improvements of processes, systems or products to enhance performance of the job area. Analysis provided is in-depth in nature and often provides recommendations on process improvements.
  • Communication and Influence: Communicates with senior internal and external customers and vendors. Exchange information of facts, statuses, ideas and issues to achieve objective, and influence decision making.
  • Leadership and Talent Management: May provide guidance, coaching and training to other employees within job area. May manage projects, requiring delegation of work and review of others' work product.
  • Required Knowledge and Experience: Requires advanced knowledge of job area combining breadth and depth, typically obtained through advanced education combined with experience. May have practical knowledge of project management. Requires a University Degree and minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience

 

Posted: September 24, 2021, 6:25 am
Category : Packaging Engineer
Job Type : Contract
Id : 8471
Region : Twin Cities

The Sr. Packaging Engineer designs, develops, and tests a wide variety of containers used for the protection, display, and handling of products. Determines packaging specifications according to the nature of the product, cost limitations, legal requirements, and the type of protection required, considering need for resistance to such external variables as moisture, corrosive chemicals, temperature variations, light, heat, rough handling, and tampering. Designs package exteriors considering such factors as product identification, sales appeal, aesthetic quality, printing and production techniques. Responsibilities may include documentation management and/or coordination of Good Manufacturing Practices (GMPs), and may support prototype line development in manufacturing facilities/plants.

Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering and overseeing the projects from design to implementation while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education (typically University).

  • Autonomy: Seasoned individual contributor. Works independently under limited supervision to determine and develop approach to solutions. Coaches and reviews the work of lower level specialists; may manage projects / processes.
  • Organizational Impact: May be responsible for entire projects or processes within job area. Contributes to the completion of work group objectives, through building relationships and consensus to reach agreements on assignments.
  • Innovation and Complexity: Problems and issues faced are difficult, and may require understanding of multiple issues, job areas or specialties. Makes improvements of processes, systems or products to enhance performance of the job area. Analysis provided is in depth in nature and often provides recommendations on process improvements.
  • Communication and Influence: Communicates with senior internal and external customers and vendors. Exchange information of facts, statuses, ideas and issues to achieve objective, and influence decision making.
  • Leadership and Talent Management: May provide guidance, coaching and training to other employees within job area. May manage projects, requiring delegation of work and review of others' work product.
  • Required Knowledge and Experience: Requires advanced knowledge of job area combining breadth and depth, typically obtained through advanced education combined with experience. May have practical knowledge of project management. Requires a University Degree and minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience.


Posted: September 22, 2021, 2:14 pm
Category : Test Engr - Technical
Job Type : Contract
Id : 8470
Region : Twin Cities

This Test Engineer position is responsible for providing key technical expertise and organizational leadership and focus for developing the test capability necessary to evaluate products to meet standards compliance, regulatory approval, and business’s needs. This position provides support that spans the full range of research, technology, and development of new and derivative products.

The Test Engineer must be able to work with designers and reliability engineers and technicians to develop and execute strategies that provide the test capabilities necessary to drive decisions and support regulatory submission.

General Responsibilities:

  • Work to effectively plan and provide test capabilities early in project development and drive the identification and proper collection of test objectives, requirements, measures, and metrics.
  • Understand applicable product/system test requirements and provide inputs.
  • Develop, validate, implement test methods and systems to meet design and reliability requirement by collaborating with Design, Reliability, Operations, Regulatory Affairs, and other cross-functional partners. Must be established and productive individual contributor. Works independently with general supervision on larger, moderately complex projects / assignments
  • Lead and execute Installation Qualifications (IQ)
  • Perform re-validation on legacy methods and system
  • Contribute to the completion of group objectives, through building relationships and consensus to reach agreements on assignments.
  • Problem solver. Problem and issues faced in this position are general, and may require understanding of broader set of issues or other job areas but typically are not complex.
  • Makes improvements to processes, systems to enhance better performance.
  • Provide guidance, coaching and training to other lower engineers and Technicians
  • Manages projects, delegation of work and review of reports from others.
  • Lead and participate both mechanical and electrical test development.
  • Communicate clearly the project plans and deliverables to management and project teams where applicable.
  • Supports ISO-17025 lab accreditation.

Minimum Requirements:

  • 4-year advanced engineering degree required. Strong electrical background is preferred
  • Proficient with Microsoft Office applications (Excel and Word)
  • Minimum of 2 years of applicable experience.
  • Knowledge of Verification and Validation (V&V) practices and techniques.
  • PROBLEM SOLVING skills, including demonstrated application of structured problem solving methods and tools
  • Familiar with statistical analysis tools such as Minitab or JMP
  • Experience with testing in both a manual and automated environment
  • Familiar with ISO-17025 lab accreditation


Posted: September 21, 2021, 11:46 am
Category : Quality Engineer - Medical Device
Job Type : Contract
Id : 8469
Region : Twin Cities

Seeking a Quality Engineer to initiate medical device quality assurance activities. These activities must be in accordance with FDA Quality System Regulation, ISO13485 and other international standards. This position will support the assessment of regulations and product standards as well as the implementation activities that are required to claim compliance. Activities will include assessing applicability, performing a gap assessment, developing an implementation plan, and executing to the implementation plan. Interface and take lead QA role in interactions with cross function members where needed to complete the assessments. Update and maintaining the quality system for external requirements systems management to continue to drive to be best in class.



Posted: September 17, 2021, 11:36 am
Category : Hardware Engineer
Job Type : Contract
Id : 8468
Region : Twin Cities

The Sr. Electrical Design Engineer – R&D Conducts research, design, development, and testing of electrical or mechanical hardware such as computer chips, circuit boards, mechanical and electrical components. Ensures reliability, develops technical specifications for production, analyzes hardware configuration and processing solutions, and tests hardware conformance to specifications; may design new or modify existing products. Makes engineering computations, write specifications, and make adjustments in drawings and specifications; verifies completed design elements, checks dimensions, materials to be used, and quantities. Other responsibilities and activities:

  • Works under the guidance of a project team of engineers with minimal supervision. Plans intermediate steps to reach overall goals.
  • Creates and modifies circuit schematics and works with or directs technicians to integrate into PCB design layout providing design criteria and guidance.
  • Builds and tests circuit boards, test fixtures and prototypes and troubleshoots designs as needed.
  • Determines test procedures to be performed. Writes clear and accurate test reports, draws conclusions and makes recommendations.
  • Releases test studies, protocols, reports, specifications and other documents into the documentation system.
  • Sets up and supports functional, operational, environmental and life tests to evaluate performance and reliability of prototype or production products.
  • May provide direction or training to other engineers, technicians, interns
  • Works closely with engineers and other technicians on a project team in evaluating and improving designs or processes.

BASIC QUALIFICATIONS:

  • Proficiency in Schematic Capture and PCB layout.
  • Proficiency in specifying, building and troubleshooting engineering prototype PCBAs and product assemblies.
  • Able to specify and build PCBA interconnectivity.
  • Able to design and build electronic test fixtures.
  • Use of electronic test equipment: oscilloscopes, multimeters, frequency counters, signal generators, logic analyzers, EMC tools, sound measurement tools, microscopes, digital cameras, etc...
  • Basic knowledge of analog and digital electronics theory
  • Proficiency in hand soldering including surface mount components.
  • PC Software: MS Office Tools, Visio, Agile CM.
  • Technical packages: Cadence/Allegro, LabView, Hyperterminal.
  • Experience with production documentation of components and assemblies including Engineering Specifications, BOMs.
  • Good Troubleshooting skills
  • Demonstrated innovation/creativity
  • Technical writing skills
  • Works well in a team environment

SPECIALIZED KNOWLEDGE REQUIRED

  • In depth understanding of electro-mechanical systems utilizing embedded software
  • Direct experience with extracorporeal capital equipment platforms such as arterial pump controllers, cardiopledgia systems and peristaltic pumps.
  • Experience with Cadence/Allegro board layout tools

DESIRED/PREFERRED QUALIFICATIONS

  • Previous experience in medical device product development
  • Experience with Labview
  • General Programming knowledge specifically in C++ and Python


Posted: September 17, 2021, 9:51 am
Category : Software Test Engineer
Job Type : Contract
Id : 8466
Region : Twin Cities

We are seeking high caliber Software Verification Engineer to join our Software Verification team. This Engineer will bring testing expertise to the innovative, and fast-paced verification team. This high caliber, motivated and passionate individual will be responsible for requirements analysis, test design, test execution, defect issue resolution.

Responsibilities include:

  • Work independently and as a team member to plan, write, and execute test cases according to Company practices, FDA regulatory, and ISO standard procedures.
  • Design new test suites for new features and functionality.
  • Perform dry runs and formal Verification activities as required.
  • Setup and configure Test Equipment.
  • Record and close defects found during V&V activities.
  • Perform requirements, design and tests reviews.

Experience and Education Required:

  • Bachelors degree in Computer Science, Computer, Electrical or Biomedical Engineering.
  • Knowledge of software testing. Knowledge of software development lifecycle management tools.
  • Organized, on-time, quick learner and detailed oriented.
  • Excellent documentation skills in delivering information that adds value to managements decision-making process.
  • Experienced in quantitative, analytical, organizational, and follow-up skills.
  • Polished communicator - written documentation and oral presentations/ discussions/ meetings.
  • Excellent reputation for building relationships across various levels of an organization.
  • Energized attitude, proactive thinker and self-starter.


Posted: September 17, 2021, 8:02 am
Category : Software Engineer
Job Type : Contract
Id : 8465
Region : Twin Cities

Seeking a Principal Software Engineer to support a new R&D product development project. We are looking for an experienced firmware/embedded software engineer to develop low-level embedded software interfacing with hardware electronics and to develop application GUI software for medical devices. This person must have experience with the entire software development process.

POSITION RESPONSIBILITIES MAY INCLUDE:

  • Responsible for the full life-cycle development including requirements analysis, design, development, unit test, debug, integration and formal qualification of firmware and application software for medical devices.
  • Conduct and participate in code walk-throughs / inspections. Work with other disciplines to develop system-minded implementations that considers safety, product security, performance, communication, user interface, and other aspects of the final product.
  • Develop, test, and qualify software tools used in the product development process.
  • Performs duties in compliance with the Quality System and project software development plan.
  • Develop software documentation throughout the development process.

BASIC QUALIFICATIONS:

  • BS in Electrical Engineering, Computer Science, or Software Engineering and a minimum of 9 years engineering experience with at least 7 years of professional software development.
  • Expertise in developing firmware for real-time, embedded applications using C, C++ or equivalent languages.
  • Experience developing algorithms, wired and wireless communication interfaces, and sensor interfaces.
  • Experience with device driver development.
  • Experience with GUI development. Experience with STMicro ARM processors or similar.
  • Experience developing software in a regulated environment.
  • Working knowledge of embedded operating systems such as FreeRTOS, OpenRTOS, eCos, Embedded Linux, VxWorks, WinCE.
  • Experience with configuration management tools – GIT, Subversion, or equivalent.
  • Skilled at using oscilloscopes, logic analyzers and other tools to analyze and debug embedded systems.
  • Experience in technical specification and report writing.
  • Ability to work in a team environment with strong collaboration skills.
  • Must be able to work with minimal supervision.
  • In depth understanding of embedded systems. Requirements management tools/databases. Knowledge of IEC 62304.

DESIRED/PREFERRED QUALIFICATIONS:

  • MS in Electrical Engineering, Computer Science, or Software Engineering and a minimum 7 years of engineering experience with at least 5 years of professional software development.
  • Experience developing software for embedded and electro-mechanical devices such as pressure monitors, motor control, position sensing, energy delivery control.
  • Experience developing software for medical instrumentations such as patient monitors, heart/lung machines, arterial blood pumps, ablation systems and in-vitro diagnostic devices.
  • Experience with requirements flow down tools such as ReqPro, Doors or Cognition Cockpit.
  • Experience with continuous integration, automated system testing and test-driven development.


Posted: September 16, 2021, 12:53 pm
Category : PC Board Designer
Job Type : Permanent
Id : 8461
Region : Twin Cities

Seeking a PCB Designer that will be integrally involved in all aspects of printed circuit board design including library maintenance, PCB layout of up to ten layers, design verification, and post-processing to prepare for manufacturing.

What You Will Be Doing:

  • Create schematic symbols, component geometries and electronic components utilizing Mentor Graphics Xpedition and PCB Library Expert software.NOTE: If you're an experienced PCB Designer but don't use Xpedition, please check the "Preferred" list at the bottom of this posting to learn what other software packages are acceptable; with your strong knowledge in one of those software packages, we're willing to train you into Xpedition.
  • Alter drawings to meet engineering requirements, and initiate Engineering Change Orders
  • Receive instruction or guidance from Senior PCB designers, Electrical Engineers and Mechanical Engineers, or the Electrical CAD Manager, and collaborate with them to make changes in design and documentation
  • Design and redesign PCBs from schematics and design requirements within the Mentor Graphics Xpedition, Designer and Design Capture software
  • Create drawings, Gerber files and other documentation for PCB fabrication, assembly and internal verification

Required:

  • Associates degree or equivalent in electronics field or similar
  • 5 to 10 years of solid PCB design experience
  • Background in PCB design for Class 2 and Class 3 rigid, rigid flex, and flexible circuit designs utilizing double sided, multilayer and HDI technologies
  • Familiar with IPC specifications and terminology as it relates to PCB manufacturing

Preferred:

  • Preferred is Mentor Graphics Xpedition schematic and PCB design software Release VX.2.0 and later, or PADS Professional VX.2 or later; also acceptable are Cadence, Altium, OrCAD or PADS Designer
  • Familiarity with Fablink and Variant manager processes for creating manufacturing documentation
  • Experience with a PLM system such as Windchill or Teamcenter


Posted: September 15, 2021, 10:11 am
Category : Manufacturing Engineer
Job Type : Contract
Id : 8460
Region : Twin Cities

The Product Engineer works under general supervision to provide global product release support and guidance to execute the release of design for release product engineering (RPE) programs. Provides support, as needed, to execute the release of design for new product introduction (NPI) programs.

A Day in the Life:

  • Analyzes, troubleshoots, and provides technical skills to RPE programs. Provides support, as needed, to NPI programs.
  • Participates in the planning and coordination of engineering projects, generating project-level documentation as appropriate.
  • Monitors projects and participates in improving operating efficiency.
  • Generates and completes plans and reports or other documentation in compliance with applicable Company procedures.
  • Provide work direction and guidance of strategy and execution to cross-functional partners in the area of product release.
  • Provide technical business unit knowledge and project direction to global cross-business teams supporting common process and systems.
  • Supports the development and approach to solutions for meeting business objectives for product release
  • Supports the liaison of cross-functional alignment in the areas of Configuration Management, Development, and related Operations functions
  • Supports defining the direction for new products, processes, standards, or operational plans by developing and implementing solutions to complex problems.
  • Responsible for production support engineering with respect to technical feasibility of product configurations
  • Assumes oversight for device and/or internally produced or externally purchased components for specified product portfolios
  • Follow all work/quality procedures to ensure quality system compliance and high-quality work.
  • Perform other related tasks as assigned.

Must Haves:

  • Bachelor’s degree with 2+ years of job-related experience, OR
  • Master’s degree with 6+ months of job-related experience

Nice to Haves:

  • Experience evaluating package design verification testing (DVT) and establishing finished good configurations.
  • Experience working in a regulated environment.
  • Experience working in a medical device environment.
  • Experience working with FDA, ISO, EN, and/or GMP standards.
  • Proven, strong detail-oriented work skills.
  • Proven ability to easily adapt to multi-task and shift priorities effectively and expediently.
  • Proficiency with common software packages (e.g., Word, Excel, Adobe Reader).
  • Demonstrated ability to work independently and with a team.
  • Demonstrated involvement in process definition and improvement.
  • Formal training in Product Data or Lifecycle Management systems.
  • Ability to learn and adapt to changes in technology, processes, or requirements.


Posted: September 15, 2021, 6:27 am
Category : BioMedical Engineer
Job Type : Contract
Id : 8459
Region : Twin Cities

Seeking a Principal Biomedical Engineer to develop biocompatibility strategies and prepare biological evaluation plan for a major medical device company.

Positon Responsibilities:

  • Coordinates and facilitates biocompatibility testing of materials and designs in accordance with FDA requirements, internal SOPs and standards.
  • Liaise with internal resources (design, regulatory, quality, clinical and manufacturing) and external resources, developing and coordinating test strategies with Contract Research Organizations (CROs) to ensure appropriate planning and execution of required testing.
  • Perform gap assessments of products by reviewing legacy documentation and evaluating device BOMs to determine the applicability of test data to ISO 10993 standard.
  • Write biological risk assessments to ensure all the relevant end points mentioned in ISO 10993 are met.
  • Develop and deliver regulatory submission responses to biocompatibility related questions.
  • Participate in the analysis of technical issues and the development of recommendations for project decisions and actions.

Required Knowledge and Experience:

  • Requires mastery of a specialty area and full knowledge of industry practices, typically obtained through advanced education combined with experience.
  • May have broad knowledge of project management.
  • Requires a University Degree and minimum 7 years of relevant experience, or advanced degree with a minimum of 5 years of relevant experience.


Posted: September 14, 2021, 8:45 am
Category : Quality Engineer - Medical Device
Job Type : Contract
Id : 8458
Region : Twin Cities

The Associate Quality Engineer develops, modifies, applies and maintains quality standards and protocol for processing materials into partially finished or finished materials product. Collaborates with engineering and manufacturing functions to ensure quality standards are in place. Devises and implements methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment. Designs or specifies inspection and testing mechanisms and equipment; conducts quality assurance tests; and performs statistical analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards and specifications. Ensures that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements. May specialize in the areas of design, incoming material, production control, product evaluation and reliability, inventory control and/or research and development as they apply to product or process quality.

Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering and overseeing the projects from design to implementation while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education (typically University).

  • Autonomy: Entry level individual contributor on a project or work team. Works with close supervision.
  • Organizational Impact: Delivers work of limited scope, typically smaller, less complex projects or related activities.
  • Innovation and Complexity: Identifies, defines and addresses problems that are not immediately evident but typically not difficult or complex. Makes minor changes in systems and processes to solve problems.
  • Communication and Influence: Communicates primarily with internal contacts within immediate group. Contacts others to gather, confirm and convey information.
  • Leadership and Talent Management: N / A job at this level is focused on self-development.
  • Required Knowledge and Experience: Requires broad theoretical job knowledge typically obtained through advanced education. Requires a University Degree, 0 years of experience required.


Posted: September 13, 2021, 7:24 am
Category : Software Engineer
Job Type : Contract
Id : 8457
Region : Twin Cities

Looking for a Principal Software Test Engineer to join an R&D Organization to lead and develop formal tests for application software for cardiac ablation systems. The Principal Software Test Engineer will also be responsible for designing processes and automated test systems to support this effort.

Areas of responsibilities will include execution of application software test system design, test requirements, test procedures, manual testing, and test automation in C#. The candidate will propose a mix of manual, semi-automated, and automated testing to be implemented depending on automation feasibility, specific functionality coverage, and program needs. Candidates must be able to plan and organize test cases and strategy, generate and review traceability to design requirements, lead and remove roadblocks for an extended, remote team, and develop and review test specifications, code, and test reports in compliance with design control procedures used within the medical device industry. Candidates must be willing to work in a fast paced, multi-tasking, team environment.

POSITION RESPONSIBILITIES

  • Lead the verification testing effort for Windows-based computing systems software, which is integrated with mechanical and electrical systems.
  • Work in an evolving, maturing Agile environment as part of scrum team, in consultation with scrum masters, product owners, and developers.
  • Investigate, propose, and implement new technologies or processes which improve the reliability and efficiency of software testing.
  • Apply the appropriate standards, processes, procedures and tools throughout the system development life cycle.
  • Effectively work with individuals from various engineering disciplines in a variety of locations, including supporting Manufacturing in troubleshooting operations through assembly and test.
  • Provide technical assistance to other functional departments such as Quality, Reliability, and Manufacturing.

BASIC QUALIFICATIONS/EDUCATION/EXPERIENCE

  • 7+ years of application/software systems testing and/or development experience with Bachelor’s Degree in Engineering (Computer Science, Software, Biomedical, or Electrical preferred), or 5+ years of experience with additional advanced degree.
  • 2+ years of direct automated application testing experience with C# language and .NET framework.
  • Strong experience in technical specification, traceability analysis, test case development, and report writing.
  • Ability to mentor, lead, and/or review the work of less experienced and/or remote engineering teams
  • Ability to work with minimal supervision.
  • Ability to work in a multi-site team environment displaying strong collaboration skills.
  • Excellent written and oral communication skills, including the ability to clearly and concisely summarize complex technical concepts and problems.

DESIRED/PREFERRED QUALIFICATIONS

  • Experience using Microsoft Visual Studio and Test Manager.
  • Experience with security techniques and protocols.
  • Experience with medical devices or other regular industries, cardiac ablation or electrophysiology products are a plus
  • Specific knowledge of FDA software validation requirements and international medical device standards such as 62304.


Posted: September 10, 2021, 8:19 am
Category : Quality Engineer - Medical Device
Job Type : Contract
Id : 8456
Region : Twin Cities

The Quality Engineer – Medical Device develops, modifies, applies and maintains quality standards and protocol for processing materials into partially finished or finished materials product. Collaborates with engineering and manufacturing functions to ensure quality standards are in place. Devises and implements methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment. Designs or specifies inspection and testing mechanisms and equipment; conducts quality assurance tests; and performs statistical analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards and specifications. Ensures that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements. May specialize in the areas of design, incoming material, production control, product evaluation and reliability, inventory control and/or research and development as they apply to product or process quality.

Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering and overseeing the projects from design to implementation while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education (typically University).

  • Autonomy: Established and productive individual contributor. Works independently with general supervision on larger, moderately complex projects / assignments.
  • Organizational Impact: Sets objectives for own job area to meet the objectives of projects and assignments. Contributes to the completion of project milestones. May have some involvement in cross functional assignments.
  • Innovation and Complexity: Problems and issues faced are general, and may require understanding of broader set of issues or other job areas but typically are not complex. Makes adjustments or recommends enhancements in systems and processes to solve problems or improve effectiveness of job area.
  • Communication and Influence: Communicates primarily and frequently with internal contacts. External interactions are less complex or problem solving in nature. Contacts others to share information, status, needs and issues in order to inform, gain input, and support decision making.
  • Leadership and Talent Management: May provide guidance and assistance to entry level professionals and / or employee in Support Career Stream.
  • Required Knowledge and Experience: Requires practical knowledge and demonstrated competence within job area typically obtained through advanced education combined with experience. Requires a University Degree and minimum of 2 years of relevant experience, or advanced degree with 0 years of experience.


Posted: September 9, 2021, 8:14 am
Category : Project Manager
Job Type : Contract
Id : 8455
Region : Twin Cities

The Equipment Engineering (EE) Project Manager supports product development programs and Operations projects. In addition, EE Project Management leads teams and coordinates deliverables across EE functions to provide quality solutions on time and within budget. The EE Project Manager has operations and/or process development expertise, and the potential ability to lead a team of representatives from multiple Operations/Process development functions.

Your Responsibilities Include:

  • Must have demonstrated strong leadership capabilities across multiple functions, an excellent ability to communicate at many levels and an ability to quickly and effectively form strong cross-functional working relationships.
  • Works cross functionally to influence, coordinate and drive activities related to Equipment Engineering deliverables.
  • Participates on cross functional project teams to develop clear specifications, influence project direction, evaluates feasibility of concepts through prototyping and risk assessment activities.
  • Applies project management skills to coordinate deliverables, develop and manage timelines, and develop estimates and manage budgets.
  • Establishes milestones and monitors adherence to master plans and schedules, identifies project problems and obtains solutions such as allocation of resources or impact of changing project requirements.
  • Leads and directs Equipment development team(s) on Equipment/Software needs of New Product Development/Technology Development/Operations programs.
  • Identifies, anticipates and manages risks critical to project success. Facilitates cross functional risk mitigation activities.
  • Provides timely and appropriate communication to site leadership and stakeholders.
  • Partner with external vendors to deliver equipment and develop technology that fulfills project requirements.

Basic Qualifications:

  • Bachelor’s degree with 5 plus years of experience, or master’s degree with 3 plus year of experience
  • Excellent verbal and written communication skills
  • Self-starter that can work with minimal supervision
  • Project lead experience working with small and large cross functional teams
  • Demonstrated excellence in data analysis, project planning, and execution

Preferred Qualifications:

  • PMP certification
  • Demonstrated ability to lead and work together with a cross-functional, multi-site team.
  • Strong organization, execution and communication skills.
  • Candidate to have strong leadership and interpersonal skills and ability to build relationships within project teams and customer.
  • Problem solving technical expertise


Posted: September 7, 2021, 12:05 pm
Category : Technician - Medical Equipment
Job Type : Contract
Id : 8453
Region : Twin Cities

Immediate opportunity for an Equipment Automation Technician, to support design, start-up, troubleshooting, and validation of automated equipment for medical device product manufacturing. This position will support Controls Engineers in machine design development, including AutoCAD Electrical design and documentation of control panels, schematics, and mechanical components, updating / programming PLC and HMI software, support repeat equipment builds, and troubleshooting and solving hardware and software (PLC, HMI, Vision) issues. Requirements include 2 year Electrical / Automation Tech degree, with training and experience in design, programming, and troubleshooting of industrial control systems. Requires proficiency with AutoCAD Electrical Cad, and training in troubleshooting PLC and HMI systems, robotics, machine vision, and controls instrumentation. Will consider entry level candidate with solid training in automated systems, or technician with up to several years of experience.



Posted: September 7, 2021, 11:37 am
Category : Controls Engineer
Job Type : Contract
Id : 8454
Region : Twin Cities

Seeking a Software Controls Engineer that develops manufacturing/test equipment and software used in the development and production of medical devices. Under limited supervisions or as member of a team: directs, develops, concepts and executes specifications, designs, plans and builds of moderately complex manufacturing and test equipment.

Key Responsibilities:

  • Participates on project teams to develop clear specifications, evaluate feasibility of concepts, and provide estimates for electrical/software designs.
  • Creates electrical/software designs utilizing the departments’ standard development tools and procedures.
  • Procures standard electrical/software components.
  • Coordinates, manages, and documents project designs, estimates, and costs.
  • Prepares standard reports/documentation to communicate status and results.
  • Leads project teams that include Designers, Engineers, and Technicians in the design, assembly, and debug of equipment.
  • Completes FDA/QSR equipment requirements by assisting in the creation of specifications and qualifications.
  • Assists in defining basic mechanical components and automated control requirements.
  • Provides training as required to ensure that the controls systems can be operated effectively.
  • Complete project deliverables and monitor project schedule and scope changes to assure team can meet delivery requirements.

Critical Qualifications:

  • User of the following languages: VB.Net and C#
  • Experience with (user) Aerotech hardware and software


Posted: September 7, 2021, 11:34 am
Category : Mechanical Engineer
Job Type : Contract
Id : 8450
Region : Twin Cities

The Product Engineer will be responsible for production support engineering with respect to testing methods, procedures, and problems; device specification and yield problems; minor redesign of devices and masks; analysis of customer returns; and optimizing device production relative to cost constraints. Assumes responsibility for device after transfer into high volume production and usually responsible for entire device manufacturing operations other than wafer fabrication. May assist customer in device usage problems or customer testing of complex devices.

Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering and overseeing the projects from design to implementation while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education (typically University).

Autonomy: Established and productive individual contributor. Works independently with general supervision on larger, moderately complex projects / assignments.

Organizational Impact: Sets objectives for own job area to meet the objectives of projects and assignments. Contributes to the completion of project milestones. May have some involvement in cross functional assignments.

Innovation and Complexity: Problems and issues faced are general, and may require understanding of broader set of issues or other job areas but typically are not complex. Makes adjustments or recommends enhancements in systems and processes to solve problems or improve effectiveness of job area.

Communication and Influence: Communicates primarily and frequently with internal contacts. External interactions are less complex or problem solving in nature. Contacts others to share information, status, needs and issues in order to inform, gain input, and support decision making.

Leadership and Talent Management: May provide guidance and assistance to entry level professionals and / or employee in Support Career Stream.

Required Knowledge and Experience: Requires practical knowledge and demonstrated competence within job area typically obtained through advanced education combined with experience. Requires a University Degree and minimum of 2 years of relevant experience, or advanced degree with 0 years of experience.



Posted: September 7, 2021, 7:44 am
Category : Systems Engineer
Job Type : Contract
Id : 8449
Region : Twin Cities

As Principal Software Systems Engineer, you will be a critical contributor in the development and deployment of software solutions to support our development programs and building compelling products within Electrophysiology Division. You will be responsible for leading feature teams in the development of complex software applications which include signal processing, algorithms and visualization in a real-time environment. You will also be working with our emerging cloud and analytics programs. All this will happen in an environment which emphasizes a robust cybersecurity and patient privacy focus. You will participate in all phases of the software lifecycle, including concept development, requirements, design, implementation, and testing.Primary Responsibilities:Lead application feature definition activities working cross-functionally with Software Development, Systems Engineering, Human Factors, Clinical Engineering, and other stakeholders.Contribute to overall project success and define necessary activities to achieve desired business results.Identify, quantify and resolve technical risks which may require cross functional collaboration to resolve complex system interactionsManage System and subsystem requirements including definition, decomposition, analysis and traceability to ensure clear and unambiguous software requirementsPlay a key role in the software/hardware integration. Collaborate with Systems Verification, Pre-Clinical engineering and other stakeholders to do root cause analysis and solution generationReviews software designs to ensure they implement the appropriate software behavior and requirementsEnsure that all activities conform to Quality and compliance requirementsAs a team leader, mentor and guide other team members to facilitate completion of various project activities, from definition, identifying software functional requirements, implementation, code reviews, traceability and final release according to medical device development processes.Required Qualifications:Bachelorâ?'s Degree in Engineering (Computer, Electrical, Computer Systems, Systems, or Software), Computer Science, or related discipline10+ years of software engineering design and development or systems engineering experienceDemonstrated knowledge and experience working with C++Experience with creating and managing requirements and translating them into effective architectures and software designExcellent verbal and written communication skills, with ability to communicate to all levels of the organizationPreferred Qualifications:Masterâ?'s Degree in Engineering (Computer, Electrical, Computer Systems, or Software), Computer Science, or related disciplineKnowledge of 62304 and other standards applicable to Class II and Class III medical devicesPrevious experience working in a regulated industry such as automotive, aerospace, healthcare, or defenseWell versed in draft FDA Cybersecurity Guidance and GDPRDemonstrated ability to provide technical leadership and mentorshipExperience with complex electromechanical systems including hardware, embedded firmware, disposables, and softwareAcademic GPA: 3.0 plus

Posted: September 2, 2021, 11:56 am
Category : Technical Writer
Job Type : Contract
Id : 8447
Region : Twin Cities

The Engineering Technical Writer creates, develops, plans, writes and edits operational, instructional, maintenance or test procedures for paper, multimedia, web based publications and user sites; may produce content for embedded user assistance technology. Conducts interviews with various users and technical staff to gather data for documentation. Researches and translates technical information into manuals and/or web based documents for nontechnical and technical users. May document engineering processes and specifications. Recommends formats responsive to technical and customer requirements. Produces products that conform to the company documentation and quality assurance standards.

Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering and overseeing the projects from design to implementation while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education (typically University).

  • Autonomy: Established and productive individual contributor. Works independently with general supervision on larger, moderately complex projects / assignments.
  • Organizational Impact: Sets objectives for own job area to meet the objectives of projects and assignments. Contributes to the completion of project milestones. May have some involvement in cross functional assignments.
  • Innovation and Complexity: Problems and issues faced are general, and may require understanding of broader set of issues or other job areas but typically are not complex. Makes adjustments or recommends enhancements in systems and processes to solve problems or improve effectiveness of job area.
  • Communication and Influence: Communicates primarily and frequently with internal contacts. External interactions are less complex or problem solving in nature. Contacts others to share information, status, needs and issues in order to inform, gain input, and support decision making.
  • Leadership and Talent Management: May provide guidance and assistance to entry level professionals and / or employee in Support Career Stream.
  • Required Knowledge and Experience: Requires practical knowledge and demonstrated competence within job area typically obtained through advanced education combined with experience. Requires a University Degree and minimum of 2 years of relevant experience, or advanced degree with 0 years of experience.


Posted: August 31, 2021, 8:45 am
Category : Manufacturing Engineer
Job Type : Contract
Id : 8446
Region : Twin Cities

Seeking a Sr. Manufacturing Engineer to be responsible for the following and other duties may be assigned.Designs manufacturing processes, procedures and production layouts for assemblies, equipment installation, processing, machining and material handling.Designs arrangement of machines within plant facilities to ensure most efficient and productive layout. Designs sequence of operations and specifies procedures for the fabrication of tools and equipment and other functions that affect product performance.Adapts machine or equipment design to factory and production conditions. May incorporate inspection and test requirements into the production plan. Inspects performance of machinery, equipment, and tools to verify their efficiency, and investigates and initiates corrective action of problems and deficiencies to ensure product quality.Develops manufacturing processes that are applicable to statistical process control, and may develop those techniques.Provides guidance to engineering regarding design concepts and specification requirements to best utilize equipment and manufacturing techniques. Ensures processes and procedures are in compliance with regulations.Nice to have:Practice with to high- and low-power laser system operation/testing/troubleshooting. Laser Optical collimation techniques, Experience with optical measuring equipment, Working knowledge of properties of light specifically lasers.Requires a University Degree and minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience.

Posted: August 30, 2021, 12:56 pm
Category : Materials Engineer
Job Type : Contract
Id : 8444
Region : Twin Cities

The Materials Engineer analyzes, researches, designs and develops materials and their related fabrication and application processes to develop and optimize materials for use in engineering design of and/or application in structures, systems and subsystems. Applies principles of chemistry, physics, and material behavior to develop metallic, nonmetallic and composite material and processing specifications, fabrication and assembly processes. Develops, analyzes and applies material properties and design allowables, processing processes and quality engineering specifications. Material analyses may include failure analysis of components, systems and subsystems, life predictions, and definition and requirement specifications. May review and approve subcontractor material processing procedures.

Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering and overseeing the projects from design to implementation while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education (typically University).

  • Autonomy: Seasoned individual contributor. Works independently under limited supervision to determine and develop approach to solutions. Coaches and reviews the work of lower level specialists; may manage projects / processes.
  • Organizational Impact: May be responsible for entire projects or processes within job area. Contributes to the completion of work group objectives, through building relationships and consensus to reach agreements on assignments.
  • Innovation and Complexity: Problems and issues faced are difficult, and may require understanding of multiple issues, job areas or specialties. Makes improvements of processes, systems or products to enhance performance of the job area. Analysis provided is in depth in nature and often provides recommendations on process improvements.
  • Communication and Influence: Communicates with senior internal and external customers and vendors. Exchange information of facts, statuses, ideas and issues to achieve objective, and influence decision making.
  • Leadership and Talent Management: May provide guidance, coaching and training to other employees within job area. May manage projects, requiring delegation of work and review of others' work product.
  • Required Knowledge and Experience: Requires advanced knowledge of job area combining breadth and depth, typically obtained through advanced education combined with experience. May have practical knowledge of project management. Requires a University Degree and minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience.


Posted: August 27, 2021, 9:07 am
Category : R&D Engineer
Job Type : Contract
Id : 8442
Region : Twin Cities

Seeking a Sr. Human Factors Engineer to join a growing team working on emerging cardiac ablation technologies. This role will lead the design of next generation cardiac ablation products, shaping the experience of its users.

Position Responsibilities

  • Provide human factors expertise to R&D teams
  • Responsible for supporting and coordinating all activities necessary to complete human factors engineering projects.
  • Conducting ethnographic user research to identify user needs
  • Translating user needs to requirements and product design concepts
  • Developing prototypes to explore and validate product design concepts
  • Performing workflow, task and use error analyses
  • Conducting Formative Usability testing
  • Conducting Summative Validation testing
  • Support program teams to ensure sound human factors principles are considered and implemented
  • Create and communicate project plans, tasks and deliverables and manage time to meet project deadlines.

Required Qualifications:

  • M.S. degree in Human Factors Engineering, or a related discipline required
  • 2+ years of relevant human factors/usability engineering or design experience
  • Proven ability to apply knowledge of human factors principles (human performance and limitations – perceptual, cognitive, motor skills, anthropomorphic) and techniques (user research, user-interface design, usability testing) to the design, development, and evaluation of hardware and/or software products
  • Experience leading Human Factors activities across the product lifecycle, including ethnographic research, user needs identification, workflow and task analysis, requirements development, user interface design, user error analysis, usability and validation testing
  • A proven ability to work with cross-functional teams and provide technical leadership
  • Experience with software and/or hardware user-interface design
  • Proven ability to interface with customers in a highly professional manner
  • Ability to quickly assimilate advanced domain knowledge
  • Excellent verbal and written communication and presentation skills.
  • 10% Travel, including Internationally, by plane and by car when COVID 19 restrictions are lifted

Preferred Qualifications and Education:

  • Ph.D. degree in Human Factors or related disciplines
  • Experience in medical device development
  • Working knowledge of cardiac electrophysiology
  • Working knowledge of Human Factors/Usability Engineering regulatory standards
  • Excellent collaboration and organization skills


Posted: August 25, 2021, 9:54 am
Category : Quality/Regulatory
Job Type : Contract
Id : 8441
Region : Twin Cities

The Associate Quality Engineer develops, modifies, applies and maintains quality standards and protocol for processing materials into partially finished or finished materials product. Collaborates with engineering and manufacturing functions to ensure quality standards are in place. Devises and implements methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment. Designs or specifies inspection and testing mechanisms and equipment; conducts quality assurance tests; and performs statistical analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards and specifications. Ensures that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements. May specialize in the areas of design, incoming material, production control, product evaluation and reliability, inventory control and/or research and development as they apply to product or process quality.

Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering and overseeing the projects from design to implementation while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education (typically University).

  • Autonomy: Entry-level individual contributor on a project or work team. Works with close supervision.
  • Organizational Impact: Delivers work of limited scope, typically smaller, less complex projects or related activities. Innovation and Complexity: Identifies, defines and addresses problems that are not immediately evident but typically not difficult or complex. Makes minor changes in systems and processes to solve problems.
  • Communication and Influence: Communicates primarily with internal contacts within immediate group. Contacts others to gather, confirm and convey information.
  • Leadership and Talent Management: N / A job at this level is focused on self-development.
  • Required Knowledge and Experience: Requires broad theoretical job knowledge typically obtained through advanced education. Requires a University Degree, 0 years of experience required.


Posted: August 25, 2021, 6:41 am
Category : Systems Engineer
Job Type : Contract
Id : 8440
Region : Twin Cities

The Systems Engineer performs software validation planning and execution through collaboration on system verification and validation strategy. Evaluates alternatives including unit test and black box testing for total system risk management. Ensures the logical and systematic conversion of user requirements, equipment requirements, and infrastructure requirements into a total system solution that acknowledges technical, schedule, and cost constraints. Performs functional analysis, timeline analysis, requirements allocation and interface definition studies to translate customer requirements into hardware and software specifications.

Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering and overseeing the projects from design to implementation while and adhering to policies, using specialized knowledge and skills.

  • Autonomy: Established and productive individual contributor. Works independently with general supervision on larger, moderately complex projects / assignments.
  • Organizational Impact: Sets objectives for own job area to meet the objectives of projects and assignments. Contributes to the completion of project milestones . May have some involvement in cross functional assignments.
  • Innovation and Complexity: Problems and issues faced are general, and may require understanding of broader set of issues or other job areas but typically are not complex . Makes adjustments or recommends enhancements in systems and processes to solve problems or improve effectiveness of job area. Previous experience performing validation on .NET and PLC applications a plus.
  • Communication and Influence: Communicates primarily and frequently with internal contacts . External interactions are less complex or problem solving in nature. Contacts others to share information, status, needs and issues in order to inform, gain input, and support decision making.
  • Leadership and Talent Management: May provide guidance and assistance to entry level professionals and / or employee in Support Career Stream.
  • Required Knowledge and Experience: Requires practical knowledge and demonstrated competence within job area typically obtained through advanced education combined with experience. Requires a University Degree and minimum of 2 years of relevant experience, or advanced degree with 0 years of experience.


Posted: August 25, 2021, 6:29 am
Category : Project Manager
Job Type : Contract
Id : 8439
Region : Twin Cities

Seeking a Sr. Project Manager with EU MDR Project Experience to lead or leverages cross functional teams to evaluate, develop and manage projects for new product development and ongoing lifecycle management of products, processes and therapies for a major medical device company.

 

POSITION RESPONSIBILITIES:

  • Oversees and manages the operational aspects of ongoing projects and serves as liaison between project management and planning, project team, and line management.
  • Manages the development and implementation process of a company's products and services involving departmental or cross-functional teams focused on the delivery of new or existing products and processes.
  • Reviews status of projects and budgets; manages schedules and prepares status reports.
  • Monitors the project from initiation through delivery.
  • Assesses project issues and develops resolutions to meet productivity, quality, and client-satisfaction goals and objectives.
  • Develops mechanisms for monitoring project progress and for intervention and problem solving with project managers, line managers, and clients.
  • Gathers requirements, works on requirements planning, requirements elicitation and requirements management to ensure they meet demands of project's key stakeholders.
  • Communicates with stakeholders, obtains stakeholder engagement to ensure the end products or processes will solve the business problems.
  • Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering and overseeing the projects – from design to implementation - while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education.

 

REQUIRED KNOWLEDGE AND EXPERIENCE:

  • Requires a Bachelors degree and minimum of 5 years of relevant experience, or advanced degree with a minimum of 3 years relevant experience.
  • EU MDR Project Experience Preferred


Posted: August 24, 2021, 6:24 am
Category : Technician - Medical Equipment
Job Type : Contract
Id : 8436
Region : Twin Cities

The Industrial Controls Technician III designs, delivers, and supports equipment solutions for a wide range of innovative medical electronics-based products and process control equipment. They are responsible for the development and release of equipment solutions supporting the release of new product manufacturing lines.

This position would be responsible for designing and implementing both the software and controls hardware solution set. The equipment solution development includes integration of software and hardware and will include debugging while interfacing to the equipment; perform R&R (repeatability & reproducibility) analyses; qualification and validation documentation, and support for system releases. This position will utilize Beckhoff hardware and software environments and/or structured text for development. This position will troubleshoot software and hardware problems using root cause analysis and provides technical solutions for equipment-related problems and provides yield improvement solutions.

POSITION RESPONSIBILITIES:

  • Developing software applications using Automated Equipment to manufacture or test electronic components utilizing Beckhoff hardware and software.
  • Designing, developing, and debugging dedicated Beckhoff hardware and software, performing verification and validation activities, performing Measurement Systems Analysis (Gage R&R studies)
  • Deployment and qualification and of equipment. Ensures appropriate documentation is maintained and completed for all technology programs transferred to product line specific areas
  • Design and qualify new custom tooling/equipment (IQ/OQ/PQ, Support)
  • Troubleshooting yield and performance issues to root cause using statistics-based analyses and providing related technical solutions
  • Following software application development procedures and demonstrate compliance through technical documentation generation
  • Work is performed with minimal direction
  • All activities must be performed in compliance with the Quality System.
  • All other duties as assigned
  • Candidates will be required to work with equipment onsite for commissioning and debugging. This may require 100% onsite work.

POSITION REQUIREMENTS:

  • High School diploma or GED
  • Preferred: Associates degree in Electrical or automation Technology
  • Preferred: Bachelors in Electrical Engineering, Controls Engineering, Industrial Engineering, Computer Engineering or related Engineering discipline
  • 4+ years of experience in Engineering Design and Development
  • 1+ years of hands on experience working with Beckhoff programmable automation controllers


Posted: August 19, 2021, 2:29 pm
Category : Electrical Engineer
Job Type : Contract
Id : 8433
Region : Twin Cities

Seeking a junior to mid-level Electrical Engineer to provide assistance to the Released Product Engineering group (a.k.a. continuation engineering, sustaining engineering, product support) for a major medical device company. This group participates in several cross functional teams for market released external medical instrumentation products. Cross functional project teams include members from Product Development, Manufacturing, Marketing, Sourcing, Contract Manufacturing Engineering, Quality, Reliability, and Regulatory functions. The group’s primary objective is to provide the design expertise necessary to support continuity of quality and compliant products. This electrical engineer will be taking work direction from the engineers on staff to fulfill various technical and documentation responsibilities.

Position Responsibilities:

  • Assess supplier driven changes, component changes, and component obsolescence for potential impact against product functional requirements and document the testing required or rationale (analysis) for no testing.
  • Create test plans and reports, and coordinate product testing.
  • Evaluate returned product to determine the root cause of field returns and establish design improvements.
  • Create and implement CO/CAs in Comany’s Product Data Management system. This includes leading the cross functional change review and approval process.
  • Communicate technical details and achieve the necessary understanding and trust from non-technical audiences.
  • Provide technical expertise to support electrical and mechanical projects that expand the capabilities of existing product and system solutions.
  • Review and analyze circuit schematics and technical component specifications.
  • Design, simulate, and test analog and digital circuits either independently or while working closely with a design technician for the development of improved solutions and evaluation of returned product.
  • Generate high quality formal documentation and records.
  • Manage, configure, track, verify, and transport test samples.
  • Assess the impact of changing regulatory standards on existing medical products and assess the impact of changes in medical products against existing regulatory standards.
  • Typical issues are reactive and are often urgent, so priorities change frequently, and issues must be resolved quickly to assure quality and continuity of supply. Some issues requiring resolution may contain a mechanical element as well. Leverage area expertise and learn new design elements to quickly become the design expert as issues require.

Required Qualifications:

  • 0 to 5 years industry experience
  • Bachelor of Electrical Engineering or another engineering discipline with a very strong focus in electronics
  • Must have the capability of functioning independently as an Electrical Engineer with minimal supervision
  • Skills include analog/digital circuit design and troubleshooting, laboratory practices, circuit simulation, product testing, and design of experiments
  • Demonstrated problem solving skills
  • Strong written communication skills
  • Proven experience working effectively both independently and with multi-functional teams.

Desired Qualifications:

  • Experience in a regulated industry (e.g. medical, aerospace, military).
  • Experience in the development or support of medical products
  • Experience with evolving technology such as USB, Bluetooth, mobile (cellular) technology, and WiFi
  • Experience in manufacturing or post market support
  • General understanding of how to interpret and apply industry recognized standards, especially for medical electronic products
  • Strong verbal skills
  • Experience with quick turn assignments


Posted: August 18, 2021, 12:17 pm
Category : Mechanical Designer
Job Type : Contract
Id : 8429
Region : Twin Cities

Seeking a Principal Mechanical Design Engineer with cardiac implantable (leads/catheter) design expertise with a Technical Leader skillset. This individual will serve as a team member assigned to short term engagements on projects as needed. Initial assignment requires knowledge of cardiac implantables (leads/catheters), their design, and steroid drug interaction/usefulness.

This Engineer will orchestrate the identification of technical strategies, solving of technical problems and completion of deliverables, among team members both internal and external to the design group. React to challenges, set-backs, scope-changes, etc., formulating an action plan, and leading the design team to forge a new path forward. Lead, direct, and/or review the work of technical team to execute the technical plan.

POSITION RESPONSIBILITIES:

Design

  • Design, develop, analyze, troubleshoot and provide technical skills during research and/or product development
  • Translate customer needs to device or therapy concepts
  • Create prototype concepts and lead down selection process for final concept
  • Institute design changes based on internal and external customer feedback
  • Perform job functions in accordance with applicable GMP and ISO standards
  • Comply with applicable FDA and international regulatory laws and standards

Deliverables/Documentation

  • While working with other team members, complete the deliverables such as VOx Assessment, Solution Definition, Risk Register, Design Input Requirements, Design Specification, Print generation, Design Characterization/DRM tasks, Solution Definition TAC, Design Validation, Process Planning Matrix, regulatory submission-ready documents for the FDA and other regulatory bodies, and others as necessary. While ultimately accountable for these tasks, may delegate responsibility as appropriate for individual deliverables.
  • Write protocols, reports, and presentation of analytical and interpretative nature to communicate results

Testing & Analysis

  • Designs studies to investigate specific performance and therapy attributes
  • Responsible for technical execution of experiments utilizing DRM methodologies; define and develop tests and test methods to meet product requirements
  • Define QMS approach such as to leverage designs/documentation
  • Assess the performance of developed devices through execution of structured experimental plans to drive data-based decisions
  • Perform risk / failure mode assessment, plan and conduct performance and safety testing and ensure mitigations are in place for designs
  • Partake in verification and validation of designs and processes

POSITION REQUIREMENTS:

  • Education Required: Engineering degree
  • Years’ Experience Required: 10+
  • Lead/Catheter design
  • Pharma, especially as related to steroid use on implants
  • Bench test and test method experience
  • Risk burn down methodology
  • Agile experience
  • Design control experience
  • Understand anatomy, disease states, clinical use cases and user interface requirements and using these to drive the definition of product requirements
  • Interact and build relationships with physicians as well as sales and marketing partners


Posted: August 13, 2021, 7:41 am
Category : Project Leader
Job Type : Contract
Id : 8427
Region : Twin Cities

The Program Analyst is responsible for coordinating, establishing, and reporting predictable program schedules for new product introduction (NPI) and release product management (RPM) programs within an Implantable Medical device R&D PMO organization. Works closely with program leadership and cross-functional project team(s) to lead project management activities. In addition to supporting the overall project management infrastructure (metrics, reporting, administration, business reviews, etc.), this role will participate in implementing best practice tools and techniques in project management.

A Day in the Life

  • Leverages cross functional teams to evaluate, develop and manage projects for new product development and ongoing lifecycle management of products, processes, and therapies.
  • Coordinates the operational aspects of ongoing projects and serves as liaison between project teams and functional management.
  • Coordinates the development and implementation process of products and services involving departmental or cross-functional teams focused on the delivery of new or existing products and processes.
  • Reviews status of projects and budgets; manages schedules and prepares status reports.
  • Monitors the project(s) from initiation through delivery.
  • Assesses project issues and develops resolutions to meet productivity, quality, and client-satisfaction goals and objectives.
  • Develops mechanisms for monitoring project progress and for intervention and problem solving with project managers and stakeholders.
  • Gathers project planning requirements, works on requirements planning, requirements elicitation and requirements management to ensure they meet demands of project’s key stakeholders.
  • Communicates with stakeholders, obtains stakeholder engagement to ensure the end products or processes will solve the business problems.
  • Deliver predictable schedules involving R&D systems or initiatives related to new technologies or therapies – from design to implementation - while adhering to policies, using specialized knowledge and skills.
  • Supports or leads enhancements of systems and processes to solve problems or improve effectiveness of job area.
  • Other responsibilities, as required and assigned.

Must Haves

  • Bachelor’s degree with 2+ years of job-related experience, OR
  • Master’s degree with 0 years of job-related experience

Nice to Haves

  • 1+ years of project management experience
  • 2+ years in medical device product development, or other highly regulated environment.
  • Project Management Professional (PMP) certified.
  • Demonstrated skill set in project leadership practices including ability to balance risk, effectively influence diverse teams, and ownership of responsibility for outcomes.
  • Demonstrated downward, lateral, and upward communication skills.
  • Demonstrated balance of detailed tactical thought processes applied to high-level strategy.


Posted: August 12, 2021, 6:28 am
Category : Quality/Regulatory
Job Type : Contract
Id : 8424
Region : Twin Cities

The Sr. Supplier Quality Engineer drives improvement and corrective action in the quality of components sourced from outside suppliers for a major medical device company. Provides technical support in the selection of suppliers. Develops acceptance criteria for materials. Monitors supplier performance to drive supplier corrective action, manufacturing yield issues and field failures. Responsible for compliance with applicable Corporate and Divisional Policies and procedures.

  • Assess potential new suppliers for technical, quality and manufacturing capabilities. Provides technical support for the introduction of components from a new supplier.
  • Generates and maintains incoming inspection procedures. Trains inspectors to these procedures.
  • Develops and/or sources inspection tools and equipment.
  • Assists in generating component specifications.
  • Generate test protocols, monitor testing, issue qualification test reports and approve components for use in products.
  • Provide input to Design Engineering on new component technology and assist in component selection with quality and reliability analysis.
  • Analyzes incoming material defects. Dispositions and drives corrective action as necessary. Communicates issues to suppliers.
  • Reviews new design specifications and provides input from component quality and manufacturability perspective.
  • Investigates field failures related to supplier materials. Develop corrective action plan where necessary.
  • Will perform this job in a quality system environment. Failure to adequately perform tasks can result in noncompliance with governmental regulations.
  • May lead a project team of moderate scope.
  • Provides guidance to less experienced staff.

Requirements:

  • BS degree in engineering or related scientific field plus 9 years of related work experience with a good understanding of specified functional area, or Master's degree with 0-2 years of related work experience.


Posted: August 6, 2021, 1:37 pm
Category : Manager
Job Type : Permanent
Id : 8422
Region : Twin Cities

Seeking an Engineering Manager to direct, manage, and supervise catheter engineers and technicians in the design, development, and testing of disposable medical devices used in interventional cardiac MR (iCMR) procedures. This position is responsible for complying with the Quality System requirements and carrying out responsibilities as outlined in the environmental, health, and safety policies. 

 

Responsibilities

  • Manage team resources to ensure products are developed on-time and conform to the organization's specifications.
  • Collaborate with other engineering disciplines, management, sales and marketing, and related departments as necessary to determine engineering feasibility, cost effectiveness, and demand for engineering products and services.
  • Hire, train and manage employees and their activities to ensure high performance and accountability, collaboration, respect for diversity, and employee job satisfaction.
  • Develop processes, policies, and procedures and ensure all engineering projects align with the organization's objectives.
  • Provide scheduling and budgetary input to overall Engineering department strategy.

 

Qualifications

  • BA/BS in engineering or related field.
  • 5 years minimum engineering experience, preferred in the medical device industry.
  • 2 years minimum management experience.
  • Prior experience managing engineering teams is desired.
  • Catheter development experience a plus, but not required.
  • Demonstrate the ability to identify and manage proficiencies and deficiencies in the department (e.g. skills, resources, etc.).
  • Demonstrate the ability to communicate priorities and decisions clearly and effectively.
  • Experience with Microsoft Office: Word, Excel, PowerPoint.


Posted: August 6, 2021, 6:07 am
Category : Software Engineer
Job Type : Permanent
Id : 8420
Region : Twin Cities

Seeking a Software Engineer to be responsible for the implementation of software for sensors, systems and internal manufacturing processes. A Software Engineer generally works at the direction of a Senior Software Engineer, Software Architect or Systems Engineer.

Core Responsibilities

  • Implement software for sensors, systems, fixtures and internal infrastructure projects.
  • Write unit tests and stress tests for validation of software performance
  • Assist in testing software releases for other members of the team
  • Document software designs and instructions for use
  • Support and maintain software that is released to internal and external customers
  • Participate in software process improvement team
  • Stay up to date on latest software techniques and trends

Experience, Education and Competencies Required

  • BS Degree in Computer Science or Electrical Engineering (or similar)
  • Proficiency in C# programming
  • Working knowledge of Microsoft Visual Studio and source control tools

Experience, Education and Competencies Preferred

  • Experience in C++ programming
  • Experience in Matlab or Python programming
  • Experience with user interface design with Winforms and WPF
  • Experience with communication protocols such as RS-232, TCP/IP and USB 3.0
  • Experience with image acquisition systems and image processing software
  • Experience working with multi-discipline engineering teams


Posted: August 5, 2021, 2:02 pm
Category : Mechanical Engineer
Job Type : Contract
Id : 8418
Region : Twin Cities

Seeking an experienced Mechanical Design Engineer to research, plan, design, verify, validate and develop mechanical and/or electromechanical products and systems for a major medical device company.  The ideal candidate should be able to recommend various technology options or approaches for system, processes, facility or program improvements in terms of safety, performance, efficiency or costs. May be responsible for the transfer from R&D to manufacturing

 

Required Experience:

  • Bachelors degree with previous mechanical design or manufacturing engineering experience
  • Technical writing
  • Rapid Prototyping
  • Experience with medical device instruments or consumer electronics is a plus


Posted: August 4, 2021, 10:02 am
Category : Software Engineering
Job Type : Contract
Id : 8417
Region : Twin Cities

Seeking a Principal Software Engineer to provide services in connection with the design, development, and quality assurance of company’s Primary Battery Life Test features and applications against a jointly prioritized backlog of features and enhancements for a major medical device company. The features include:

  • Commissioning and calibration station (requires strengths in LabVIEW 17 and REST commands)
  • Configuration station (requires strengths in C#, .net, database queries)

Additional Responsibilities:

  • Continually updating and prioritizing business requirements in the form of a JIRA backlog
  • Automated test case development for new and updated features
  • Documentation and knowledge transfer to company resources regarding architecture updates and API changes
  • Delivery management; including in Sprint documentation and reporting

Required Knowledge and Experience:

  • Bachelor of Science with a minimum 7 years of relevant experience, or advanced degree with a minimum of 5 years of relevant experience


Posted: August 4, 2021, 6:25 am
Category : Hardware Engineer
Job Type : Contract
Id : 8416
Region : Twin Cities

Seeking a Sr. Hardware Engineer to work within the Pre-mkt Quality, Cardiac Rhythm Management Business for a major medical device company.

Responsibilities may include the following and other duties may be assigned:

  • Conducts reliability analysis, and testing of electrical or mechanical hardware such as computer chips, circuit boards, mechanical and electrical components.
  • Ensures reliability, analyzes hardware configuration, leads risk analysis (FMEA/FTA), and tests hardware conformance to specifications.
  • Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering and overseeing the projects from design to implementation while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education (typically University).
  • Autonomy: Seasoned individual contributor. Works independently under limited supervision to determine and develop approach to solutions. Coaches and reviews the work of lower level specialists; may manage projects / processes.
  • Organizational Impact: May be responsible for entire projects or processes within job area. Contributes to the completion of work group objectives, through building relationships and consensus to reach agreements on assignments.
  • Innovation and Complexity: Problems and issues faced are difficult, and may require understanding of multiple issues, job areas or specialties. Makes improvements of processes, systems or products to enhance performance of the job area. Analysis provided is in depth in nature and often provides recommendations on process improvements.
  • Communication and Influence: Communicates with senior internal and external customers and vendors. Exchange information of facts, statuses, ideas and issues to achieve objective, and influence decision making.
  • Leadership and Talent Management: May provide guidance, coaching and training to other employees within job area. May manage projects, requiring delegation of work and review of others' work product.
  • Required Knowledge and Experience: Requires advanced knowledge of job area combining breadth and depth, typically obtained through advanced education combined with experience. May have practical knowledge of project management. Requires a University Degree and minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience.


Posted: August 3, 2021, 10:12 am
Category : Project Leader
Job Type : Permanent
Id : 8414
Region : Twin Cities

Seeking a Machining Supervisor to lead, supervise, and coordinate work activities within assigned Machine Shop and/or Tube Shop work centers (areas included are the CNC Lathes which include standard single spindle single turret, twin spindle twin turret and mill turn machines, CNC Horizontals Mills and CNC vertical mills, cylindrical grinding, and Swiss machining, Manual Machining, saw operations, and Anodizing) in a manner which is consistent with Company policies and procedures.

Qualifications:

  • High school education or equivalent, plus at least 2 years of technical training in machine tool technology or a related field.
  • At least 5 years of CNC milling/turning/grinding set-up and operating experience, most of which must be in a short run environment involving a series of complicated operations. At least 2 years of experience in supervisory capacity.
  • Advanced knowledge of blueprint reading, geometric dimensioning and tolerancing, SPC, and mechanical inspection.
  • Knowledge of programming and multi-axis concepts in both manual and CNC environments.
  • Very strong mechanical aptitude and problem solving skills.
  • Ability to set-up, operate, and verify the quality of work on a wide variety of CNC and manual milling/turning work centers.
  • Experience with close tolerances and precise measurements.
  • Must exhibit strong leadership and sound decision making skills.
  • Ability to communicate effectively, both verbally and in writing, with a wide variety of company personnel and others at all levels.
  • Strong project management skills.
  • Understanding of 5S and help implement continuous improvement efforts.


Posted: August 2, 2021, 7:28 am
Category : Packaging Engineer
Job Type : Contract
Id : 8412
Region : Twin Cities

The Sr. Packaging Engineer designs, develops, and tests a wide variety of containers used for the protection, display, and handling of products. Determines packaging specifications according to the nature of the product, cost limitations, legal requirements, and the type of protection required, considering need for resistance to such external variables as moisture, corrosive chemicals, temperature variations, light, heat, rough handling, and tampering. Designs package exteriors considering such factors as product identification, sales appeal, aesthetic quality, printing and production techniques. Responsibilities may include documentation management and/or coordination of Good Manufacturing Practices (GMPs), and may support prototype line development in manufacturing facilities/plants.

Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering and overseeing the projects from design to implementation while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education (typically University).

  • Autonomy: Seasoned individual contributor. Works independently under limited supervision to determine and develop approach to solutions. Coaches and reviews the work of lower level specialists; may manage projects / processes.
  • Organizational Impact: May be responsible for entire projects or processes within job area. Contributes to the completion of work group objectives, through building relationships and consensus to reach agreements on assignments.
  • Innovation and Complexity: Problems and issues faced are difficult, and may require understanding of multiple issues, job areas or specialties. Makes improvements of processes, systems or products to enhance performance of the job area. Analysis provided is in-depth in nature and often provides recommendations on process improvements.
  • Communication and Influence: Communicates with senior internal and external customers and vendors. Exchange information of facts, statuses, ideas and issues to achieve objective, and influence decision making.
  • Leadership and Talent Management: May provide guidance, coaching and training to other employees within job area. May manage projects, requiring delegation of work and review of others' work product.
  • Required Knowledge and Experience: Requires advanced knowledge of job area combining breadth and depth, typically obtained through advanced education combined with experience. May have practical knowledge of project management. Requires a University Degree and minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience.


Posted: July 30, 2021, 11:22 am
Category : Software Engineer
Job Type : Contract
Id : 8411
Region : Twin Cities

The Principal Software Engineer designs, develops, tests, debugs and implements operating systems components, software tools and utilities. Determines systems software design requirements. Ensures that system improvements are successfully implemented and monitored to increase efficiency. Generates systems software engineering policies, standards and procedures.

Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering and overseeing the projects from design to implementation while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education (typically University).

  • Autonomy: Recognized expert, managing large projects or processes. Exercises considerable latitude in determining deliverables of assignments, with limited oversight from manager. Coaches, reviews and delegates work to lower level specialists.
  • Organizational Impact: Contributes to defining the direction for new products, processes, standards, or operational plans based on business strategy with a significant impact on work group results. May manage large projects or processes that span outside of immediate job area.
  • Innovation and Complexity: Problems and issues faced are difficult, moderately complex and undefined, and require detailed information gathering, analysis and investigation. Develops solutions to moderately complex problems, and/or makes moderate to significant improvements of processes, systems or products independently to enhance performance of job area. Implements solutions to problems.
  • Communication and Influence: Represents organization as a primary contact for specific projects and initiatives; communicates with internal and external customers and vendors at various levels. May negotiate with others to reach understanding or agreement, and influence decision-making.
  • Leadership and Talent Management: Typically provides guidance, coaching and training to other employees within job area. Typically manages major / moderately complex projects, involving delegation of work and review of work products, at times acting as a team leader.
  • Required Knowledge and Experience:  University Degree and minimum 7 years of relevant experience, or advanced degree with a minimum of 5 years of relevant experience.

 

Must Have

  • C# (.NET) programming
  • C# Application
  • Unit tests
  • DevOps
  • GIT
  • C++
  • Linux

 

Nice to Have

  • Hardware Emulation


Posted: July 29, 2021, 8:12 am
Category : Mechanical Engineer
Job Type : Contract
Id : 8406
Region : Twin Cities

Seeking an experienced Process Engineer to help with Project planning and Process mapping on an upcoming development project and support process development deliverables for a high priority ongoing development project for a major medical device company. Looking for an Engineer with prior upstream project planning experience preferred. Also prior process development and/or equipment development and characterization experience preferred to make up lost ground on initial installations, configuration and setup, IQ inputs (TIRs, Cals, PMs, etc) and other needs as they arise for the ongoing development project. Ideal candidate will have some relevant process engineering background, highly motivated and driven and has the potential to work under minimal direction. The candidate should be a good team player, proactive, strong execution of deliverables, timely escalations as needed and good team communication

Bachelors degree in a related field and 2-5 years experience required.



Posted: July 23, 2021, 8:25 am
Category : Reliability Engineer
Job Type : Contract
Id : 8404
Region : Twin Cities

The Software Reliability Engineer develops, coordinates and conducts technical reliability studies and evaluations of engineering design concepts and design of experiments (DOE) constructs. Recommends design or test methods and statistical process control procedures for achieving required levels of product reliability. Completes risk analysis studies of new design and processes. Compiles and analyzes performance reports and process control statistics; investigates and analyzes relevant variables potentially affecting product and processes. Ensures that corrective measures meet acceptable reliability standards. Analyzes preliminary plans and develops reliability engineering programs to achieve company, customer and governmental agency reliability objectives. May develop mathematical models to identify units, batches or processes posing excessive failure risks. As necessary, proposes changes in design or formulation to improve system and/or process reliability. May determine units and/or batches requiring environmental testing, and specifies minimum number of samples to obtain statistically valid data.

Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering and overseeing the projects from design to implementation while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education (typically University).

Autonomy: Established and productive individual contributor. Works independently with general supervision on larger, moderately complex projects / assignments. Organizational Impact: Sets objectives for own job area to meet the objectives of projects and assignments. Contributes to the completion of project milestones. May have some involvement in cross functional assignments.

Innovation and Complexity: Problems and issues faced are general, and may require understanding of broader set of issues or other job areas but typically are not complex. Makes adjustments or recommends enhancements in systems and processes to solve problems or improve effectiveness of job area.

Communication and Influence: Communicates primarily and frequently with internal contacts. External interactions are less complex or problem solving in nature. Contacts others to share information, status, needs and issues in order to inform, gain input, and support decision making.

Leadership and Talent Management: May provide guidance and assistance to entry level professionals and / or employee in Support Career Stream.

Required Knowledge and Experience: Requires practical knowledge and demonstrated competence within job area typically obtained through advanced education combined with experience. Requires a University Degree and minimum of 2 years of relevant experience, or advanced degree with 0 years of experience.



Posted: July 22, 2021, 1:23 pm
Category : Software Test Engineer
Job Type : Permanent
Id : 8392
Region : Twin Cities

Seeking a Sr. Software Test Engineer- LabVIEW to provide end to end development of TestStand/LabVIEW solutions for custom functional test systems including, writing requirements; test system development and integration; acceptance testing and technical support.

 

Major Areas of Accountability:

  • Develop LabVIEW software test system requirements
  • Design LabVIEW software solutions that satisfy test system requirements
  • Lead or participate in design review meetings
  • Collaborate with other engineering disciplines to ensure effective overall system design
  • Provide technical leadership on projects involving multiple engineers, including leading the overall design approach partitioning work among the team and sequencing detailed design activities to support the overall project schedule
  • Support the sales process by providing technical expertise in customer proposals
  • Provides effective communication with project team members, including project status, risks and suggestions to project leadership
  • Collaborate with customers as needed to accomplish customer goals

 

Education and Experience:

  • Bachelor's Degree in Electrical Engineering, Computer Science or equivalent experience in a test engineering environment
  • 5 – 10 years of work experience using TestStand and LabVIEW
  • CLD or CLA is preferred

 

Knowledge, Skills, and Abilities:

  • Ability to design TestStand and LabVIEW architectures based on system requirements
  • Application software development skills in Microsoft Visual Studio (VB.NET/C#). C/C++ experience a plus
  • Analyze existing test solution (electrical/software) and understand the design for maintenance or updating/upgrading test software
  • Solid analytical skills; able to resolve technical problems with innovative solutions
  • Proven ability to manage working on multiple projects at a time while paying strict attention to detail
  • Proficiency with Microsoft Office Suite
  • Effective verbal and written communication skills
  • Capacity to deal with a high workload and deadline pressure
  • Requires a strong initiative, proactive nature and a sense of urgency
  • Ability to travel 0% - 10% to client locations for meetings and/or system installations
  • Ability to work extended hours as necessary to meet deadlines
  • Must be able to perform in a team environment with good interpersonal skills with commitment to the highest quality achievable
  • Maintains confidentiality and security of intellectual property (ITAR, Prototype)


Posted: July 8, 2021, 8:23 am
Category : Mechanical Engineer
Job Type : Permanent
Id : 8375
Region : Twin Cities

Seeking a Mechanical Engineering Manager to be responsible for leading and supervising a team of highly skilled mechanical engineers and designers as they provide technical solutions to address our customers challenging medical device development programs. These programs include complex electromechanical systems from mobile health devices to implantables.

Essential Duties and Responsibilities:

  • Perform lead engineering role as sole engineer or as part of a team.
  • Recruit and maintain staff. Resources projects with employees, independent contractors, and temporary contractors.
  • Mentors/coaches staff. Develops and leads staff to establish and maintain excellence in technical expertise.
  • Sets work direction and oversees engineering work. Assists with overcoming roadblocks.
  • Works hand in hand with staff, Program Managers and customers to ensure optimal and sound engineering solutions are implemented within budget and schedule.
  • Keep abreast of regulations, standards and provide training to staff and others.
  • Responsible for identification, purchase, training, and maintenance of tools and equipment.
  • Support internal groups across the organization.
  • Establishes and maintains processes/procedures. Ensures policies and processes are followed. Effectively creates and supports process enhancement initiatives.

To perform the job successfully, an individual should demonstrate the following competencies:

  • Achievement Focus - Sets and achieves challenging goals; demonstrates persistence and overcomes obstacles; measures self against standard of excellence; recognizes and acts on opportunities; takes calculated risks to accomplish goals.
  • Communications - Expresses ideas and thoughts verbally; expresses ideas and thoughts in written form; exhibits good listening and comprehension; keeps others adequately informed; selects and uses appropriate communication methods.
  • Managing Customer Focus - Promotes customer focus; establishes customer service standards; provides training in customer service delivery; monitors customer satisfaction; develops new approaches to meeting customer needs.
  • Managing People - Includes staff in planning, decision-making, facilitating and process improvement; takes responsibility for subordinates' activities; makes self-available to staff; provides regular performance feedback; develops subordinates' skills and encourages growth; solicits and applies customer feedback (internal and external); fosters quality focus in others; improves processes, products and services; continually works to improve supervisory skills.
  • Planning and Organization - Prioritizes and plans work activities; uses time efficiently; plans for additional resources; sets goals and objectives; organizes or schedules other people and their tasks; develops realistic action plans.
  • Problem Solving - Identifies and resolves problems in a timely manner; gathers and analyzes information skillfully; develops alternative solutions; works well in group problem solving situations; uses reason even when dealing with emotional topics.

Supervisory Responsibilities:

  • Directly supervises employees - Carries out supervisory responsibilities in accordance with the organization's policies and applicable laws.
  • Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.

Education/Experience:

  • Bachelor of Science degree in science related field
  • Minimum of 7+ years of experience with demonstrated success in Medical Product Development Minimum 3 years in a leadership role.
  • Knowledge of medical device Regulations (examples: 21 CFR, ISO 13485, ISO 14971, ISO 9001, etc.).
  • Comprehensive knowledge of mechanical engineering in a regulated field is a must.


Posted: June 25, 2021, 11:25 am
Category : Electrical Engineer
Job Type : Permanent
Id : 8338
Region : Twin Cities

We are looking for a Senior Electrical Engineer who will play an integral role in our R&D team, working the start to finish process of planning through implementation in production of our electronic components for our high precision semiconductor inspection and measurement sensors. This position is responsible for project planning, design, implementation, design verification, transition to production, continuation, and communication of their activities to internal customers.

Core Responsibilities:

  • Interpret customer and internal product requirements and translate into product specifications, risks, and design concepts.
  • Risk reduction through feasibility studies of initial electronics concepts.
  • Contribute to project planning by estimating tasks, resources, schedules, NRE, production costs, and manufacturing support.
  • Design electrical circuits that encompass analog processing of highly accurate sensors, analog to digital conversion, high speed processor design, high speed memories, WIFI, Bluetooth, QI battery charging, CMOS imagers, lasers, photodiodes, FPGA’s, and power management.
  • Supervision of PCB layout activities that must achieve challenging size, space, weight, and high-speed board requirements.
  • Manage fabrication and testing of prototype and production electrical designs.
  • Design verification to internal specifications and standards.
  • Ability to design products to meet CE and other international compliance requirements.
  • Development of manufacturing calibration and alignment processes.
  • Transition of new designs to manufacturing and support of existing product.
  • Strong communications skills with management and other functional areas.
  • Mentoring of Junior Engineers and Technicians

Experience, Education and Competencies Required

  • Experience – 10+ years work experience including
  • Highly experienced in sensing and digitizing fundamental physical properties like; temperature, humidity, pressure, vibrations, inclination, displacement, capacitance, resistance, and others.
  • Embedded processor designs that read sensor data, process that data, and communicate the results via WIFI or Bluetooth. Design skills include processor peripherals like DDR and FLASH memories, high performance ADCs or DACs, and I2C and SPI devices.
  • Knowledge of RF fundamentals relating to WIFI and Bluetooth.
  • FPGA logic and digital signal filtering experience.
  • Wireless Li-Ion battery charging, battery fuel gauges, processor PMICs, and high efficiency power supply design.
  • Strong documentation skills that encompasses schematic capture, PCB and BOM file management, theory of operation and design descriptions, test plans and results, and design issue logging and resolution.
  • Knowledge of high-speed serial interfaces like PCIe, USB, MIPI, or USB.
  • Knowledge of CMOS imagers and machine vision standards.
  • Knowledge of international compliance requirements for electronics and radios.
  • Ability to self-manage, plan, multitask, and work effectively in a multi-functional team.
  • Mentoring of junior engineers and technicians

Preferred Experience

  • Knowledge of high speed and high-density PCB layout, propagation and impedance calculations, and fabrication methods. PCB simulation knowledge a plus.
  • MS Electrical Engineering preferred.
  • BS Electrical Engineering considered with additional experience.


Posted: May 18, 2021, 9:39 am
Category : Technicians
Job Type : Contract-to-Hire
Id : 8309
Region : Twin Cities

As a Manufacturing Technician, you will be responsible for daily manufacturing issues from production documentation, production line programming and setup. Activities will include assisting new product introduction, SMT, AOI, Robots, XY Gantry, Vision, and programming.

We are looking for a Manufacturing Technician that is a self-starter, enjoys a fast phased dynamic environment and works well in a team environment. The ideal candidate needs to be a precision-oriented professional with the ability to work efficiently within manufacturing, whose primary function and role will deal with Manufacturing Support on every level. We offer an opportunity to contribute to an innovative, forward-thinking, customer focused team, competitive compensation, and excellent benefits.

Tasks:

  • Suggest and implement continuous improvement tasks for production processes and documentation.
  • Manufacturing fixture development.
  • Acting as a manufacturing operator as needed.
  • Evaluate existing manufacturing processes and workflows to identify areas that could benefit from changes and improvements.
  • Apply working knowledge of product and assembly to the manufacturing process.
  • Participate in brainstorming sessions and cross-departmental meetings.
  • Identify and propose solutions to existing manufacturing problems.
  • Repairing equipment
  • Responding to breakdowns
  • Investigating production problems
  • Responsible for the equipment maintenance
  • Responsible for creating work instructions for manufacturing employees.
  • Responsible for keeping process documentation up to date.
  • Responsible for the prototype builds thru the production process.
  • Open to support production on first- and second shift as needed.
  • Follow QMS Policies and Procedures

Skills and Requirements:

  • Engineering aptitude, High School Graduate.
  • 3-month manufacturing experience.
  • Strong analytical, data based, problem solving skills.
  • Proficient with Windows operating systems and Microsoft Office programs.
  • Autodesk Inventor experience preferred.
  • Programming experience preferred.
  • Machining experience preferred.
  • Electrical circuit knowledge preferred.


Posted: May 4, 2021, 9:38 am
Category : Machinist
Job Type : Permanent
Id : 8264
Region : Twin Cities

Seeking a Machinist to operate CNC milling/turning/grinding machine centers and/or manual machinery in order to perform routine or repetitive operations in a manner which consistently meets customer specifications, quality requirements, and production standards.

 

Qualifications:

  • Ability to set up CNC lathes and mills.
  • Ability to set up Manual Lathes, Grinders and Mills for Manual Machining operations
  • Ability to understand and interpret programs using Mastercam software.
  • Assist with fabricating new components per Engineering drawings
  • Ability to verify work using various measurement methods.
  • Assist with modifying components per drawings or engineering's instruction
  • Work on jobs according to due date as provided using scheduling system
  • Maintain shop cleanliness.
  • Operate equipment in a safe manner
  • Communicate with other shifts
  • Work from verbal and or written instructions or sketches
  • Report job progress using current scheduling system
  • Ability to use a CAD system when needed to verify drawings
  • Mentoring of new Machinists
  • Work over time as requested
  • Work other duties as assigned

 

Knowledge and Skill Qualifications:

  • Strong math skills including trigonometry and geometry
  • Ability to read and interpret engineering drawings
  • Working knowledge of GD&T
  • Good interaction skills
  • Ability to work with minimal supervision
  • Basic computer skills
  • Demonstrate good troubleshooting and problem solving techniques
  • Basic understanding & knowledge of Machine Shop equipment, machining & measuring processes
  • Two year Machine Tool diploma or degree or equivalent experience (preferred)

 

Experience with the following type of equipment would be a plus, but not a requirement of the position:

  • Twin spindle twin turret, Y axis, live tooling, Fanuc control, Daewoo, TT1800 lathe
  • Single spindle, single turret, Y axis, live tooling, Fanuc control, Daewoo, Puma 2000Y lathe
  • Single spindle, single turret, Y axis, live tooling, Mazak Lathe
  • Mazak Vertical Mill
  • Mazak Horizontal Mill
  • Haas Vertical Mill
  • Bridgeport and Hardinge for Manual Machining operations
  • Swiss Turning
  • Cylindrical Grinding
  • Twin spindle, twin turret, Mazak Lathe
  • Mill turn, Mazak Lathe


Posted: April 8, 2021, 1:09 pm
Category : Firmware Engineer
Job Type : Contract
Id : 8178
Region : Twin Cities

Seeking a Principal Firmware Engineering for a position within the R & D product development area. This person will provide software engineering leadership with developing and commercializing a medical device system. This position will lead and be responsible for the software architecture, design, development and test for embedded electronic device components of a neuromodulation system for treatment of chronic migraines, and will provide task scoping, design cost analysis and project planning to the R&D product development area. This person will work with other engineers and technicians to achieve project milestones and product functionality.The successful candidate will be responsible for leading a software team to plan, architect, design, develop and test firmware and software for a medical device.This position will be responsible for all deliverables associated with the software products throughout the design and development lifecycle. Design and implement critical firmware elements of the design.Responsibilities include: Requirements analyses, software architecture, design and testing, creating/approving test reports, leading design reviews and code walk-through / inspections, overseeing / delegating coding, and providing technical work direction to internal or outsourced team members and support groups to achieve project objectives. Work under general direction with significant latitude to determine technical objectives of assignments. Provide mentoring and technical assistance as required to other software engineers and technicians. Support other on-going or legacy efforts as needed. Provide recommendations for tools, technologies and processes and contribute to continuous process improvement.Position Requirements: Bachelor's degree in Computer Science, Software Engineering, Electrical Engineering, or related disciplineMinimum of 7 years of relevant experience, or advanced degree with a minimum of 5 years relevant experiencePreferred Qualifications: MS in Electrical Engineering, Computer Science, or Software Engineering and a minimum 7 years engineering experience with at least 5 years of professional software development Expertise in development of firmware for real-time, embedded applications using C, C++, or equivalent languages. Experience developing algorithms, wired and wireless communication interfaces and sensor interfaces. Experience with driver development, motor control, pressure sensing and position sensing, energy delivery control, GUI design. Working knowledge of boot loaders, executives, schedulers, and real-time operating systems. Skilled at using oscilloscopes, logic analyzers and other tools to analyze and debug embedded systems. Solid communication, presentation, technical writing, and organizational skills. Experience developing software for embedded active implantable such as pacemakers, defibrillators, heart failure, or neuromodulation implantable devices. Experience developing software for embedded external instruments such as patient programmers, clinician programmers, implantable device rechargers, and patient monitors. Design and implement firmware modules for microcontrollers using Assembly and C programming language Experience working with ARM Cortex-M processors. Experience working with proprietary wireless communications systems. Experience working with battery powered systems and performing power optimization. Experience developing US FDA Class III medical devices. Knowledge of IEC 62304. Experience working with IAR Embedded Workbench for ARM and EWARM toolchain. Source code management using Git or similar tools. Defect and issue tracking using JIRA or similar tools. Programming Languages: C, C#, Python Experience developing bare-metal drivers for Microcontroller peripherals (Examples: UART, I2C, SPI, DAC, ADC, comparators). Knowledge of how to use an oscilloscope, logic analyzer, function generator, JTAG debugger and other electronics laboratory equipment.

Posted: February 15, 2021, 1:19 pm
Category : Firmware Engineer
Job Type : Contract-to-Hire
Id : 8172
Region : Twin Cities

Seeking a highly collaborative and technical Software/ Firmware Engineer Lead to help bring state of the art medical devices to market. As the software/firmware lead you will plan and coordinate development activities to ensure projects are effectively executed by the SW/FW development team that reports directly to you. You will play a technical project role in developing SW/FW and its associated documentation per established quality system procedures in addition to mentoring and growing the SW/FW team. You will work in multi-disciplinary teams to meet product and project requirements; collaborating with engineers and business leaders from a variety of companies and industries.

DUTIES AND RESPONSIBILITIES:

  • Establish the plans, processes, standards, methods, and tools for the development and verification of medical device software in compliance with IEC 62304
  • Provide technical support and cost estimates to evaluate new business opportunities
  • Writes software requirements based on system requirements
  • Create and maintain software risk management documentation such as design FMEAs in accordance with ISO 14971
  • Develop quality assurance plans to ensure compliance with quality system requirements.
  • Leads software prioritization efforts and coordinates software activities in a team environment
  • Performs scheduling activities and communicates schedule to management and customers
  • Analyzes software requirements to determine feasibility of design within time and cost constraints
  • Coordinate and facilitate software team meetings
  • Consults with hardware engineers and other engineering staff to evaluate interface between hardware and software, and operational and performance requirements of overall system
  • Translates software requirements into software architecture and design
  • Consults with customer concerning maintenance of software system
  • Coordinates configuration and release of software
  • Lead and coordinate unit, integration, and software system test activities
  • Contribute to the continuous improvement of best practices and processes within the software team
  • Will supervise others members of the engineering staff. Carries out supervisory responsibilities in accordance with the organization's policies and applicable laws.

QUALIFICATIONS:

  • Bachelor's degree in Computer Science/Engineering
  • Master's Degree in Engineering is a plus
  • Ten or more years of experience, preferable in the medical device field, including 5+years principally writing embedded software and 5+ years offering engineering leadership
  • Experience and desire to manage and develop people.
  • Experience utilizing IEC 60601, IEC 62304 (Class C), and ISO 13485 standards
  • Proficiency with two or more of the following programming languages: C, C++, Java, Java Script, HTML, C#, Python, Objective C
  • Real-time embedded systems development and debug of bare metal and RTOS platforms
  • Experience with wireless connectivity, preferably Bluetooth Low Energy is a plus
  • Understanding of basic electronics, computer architecture, microcontrollers, etc.
  • Excellent customer service skills, with an advanced understanding of internal and external customer relationship building
  • Excellent interpersonal and teamwork skills with the ability to influence, motivate, mentor, and direct team resources.
  • Ability to solve problems and implement solutions to complex problems with available resources
  • Excellent organizational, reasoning, planning, and motivational skills.
  • Good meeting practices (proper attendance, agendas, start/stop times, minutes, actions, and follow-through).
  • Self-starter; self-motivator; driven to complete projects while promoting team member success
  • Ability to adapt processes to improve inefficiencies and accelerate outcomes

COMPETENCIES:

  • Analytical--Synthesizes complex or diverse information; Collects and researches data; Uses intuition and experience to complement data; Designs work flows and procedures.
  • Design--Generates creative solutions; Translates concepts and information into images; Uses feedback to modify designs; Applies design principles; Demonstrates attention to detail.
  • Project Management--Develops project plans; Coordinates projects; Communicates changes and progress; Manages project team activities.
  • Interpersonal Skills--Focuses on solving conflict, not blaming; Maintains confidentiality; Listens to others without interrupting; Keeps emotions under control; Remains open to others' ideas and tries new things.
  • Teamwork--Balances team and individual responsibilities; Exhibits objectivity and openness to others' views; Gives and welcomes feedback; Contributes to building a positive team spirit; Put success of team above own interests; Able to build morale and group commitments to goals and objectives; Supports everyone's efforts to succeed.
  • Change Management—Develops implementation plans; Communicates changes effectively; Builds commitment and overcomes resistance; Prepares and supports those affected by change; Monitors transition and evaluates results
  • Diversity--Demonstrates knowledge of EEO policy; Shows respect and sensitivity for cultural differences; educates others on the value of diversity; promotes a harassment-free environment; Builds a diverse workforce.
  • Ethics--Treats people with respect; Keeps commitments; inspires the trust of others; Works with integrity and ethically; Upholds organizational values.
  • Strategic Thinking--Develops strategies to achieve organizational goals; Understands organization's strengths & weaknesses; Analyzes market and competition; Identifies external threats and opportunities; Adapts strategy to changing conditions.


Posted: February 11, 2021, 12:47 pm
Category : Quality Manager
Job Type : Contract-to-Hire
Id : 7993
Region : Twin Cities

We are seeking an experienced Quality and Documentation Manager to help redevelop and maintain our ISO 9001 quality management system, quality assurance as well as documentation control.

Responsibilities:

  • Work with management, engineers and floor employees to assess current engineering and production practices and improve as necessary.
  • Drive design/process capability evaluation
  • Develop quality metrics for our products and processes
  • Manage Engineering change orders and process changes, receiving inspection/Final inspection process/documentation, CoCs, deviations, internal and external corrective actions and audits.
  • Responsible of the Documentation Control and Quality Management System policies and procedures.

Qualifications:

  • B.S. in Quality, Manufacturing, Business Administration or equivalent
  • A minimum of 5 years related experience required.
  • Contract manufacturing, ISO 9001, ISO 13485, IATF 16949 experience required
  • Quality and Documentation Control Management expertise
  • Quality Assurance expertise
  • Excellent communication skills


Posted: September 21, 2020, 1:41 pm
Category : Software Engineer
Job Type : Contract
Id : 7965
Region : Twin Cities

Looking for a Software Engineer to develop and support existing machine vision inspection systems and custom automated control systems used in the development and production of medical devices. Will work within equipment/software engineering group to design machine vision systems, including concept, plans, programming, and troubleshooting for complex manufacturing and test equipment. Requires BS (CS or EE) and prefer 3 - 5+ years of experience with automated equipment development, including some hands-on vision system knowledge. Must have strong experience with .NET and C# programming and understanding of automated equipment design. Prefer experience with SQL and Cognex Vision system development. Exposure to robotic systems a plus.

 

Job Responsibilities:

  • Investigate machine vision software to identify opportunities to increase yields and/or quality of the vision system.
  • Determine root cause with regard to machine vision inspection issues.
  • Update machine vision software for enhancements and bug fixes of existing systems.
  • Investigate machine vision lighting solutions to enhance existing inspection systems.
  • Collect and analyze inspection results to prove robustness of vision system changes.
  • Integrate machine vision software system into a PC or PLC based system.
  • Troubleshoot machine vision and controls systems using pneumatic and electrical schematics.
  • Develop/Update departmental standards.
  • Create supporting design documentation.
  • Make software modifications to existing automated controls equipment.
  • Follow departmental procedures and processes when updating and developing new systems.
  • Participate on project teams to develop clear specifications, evaluate feasibility of concepts, and provide estimates for electrical/software designs.
  • Communicate costs and project status to project lead.
  • Creates electrical/software designs utilizing the departments' standard development tools and procedures.

 

Posted: July 31, 2020, 1:48 pm
Category : Sales
Job Type : Permanent
Id : 7488
Region : Twin Cities

Development Resource Group is a fast-paced, well-established engineering staffing firm seeking a motivated and energetic individual to join our growing recruiting team. Development Resource Group has been supplying contract and direct hire technical staffing since 1986 specializing in Medical Device, Engineering, R&D, and Product Development.

DRG specializes in placement of hardware, software, and mechanical engineering personnel on projects with many high tech product development companies in the Twin Cities. Our engineers are responsible for design, programming, and testing of products for medical device, electronic products, and automation systems.

The Technical Recruiter must have excellent communication skills, a high level of computer system knowledge, and preferably direct experience in sourcing, interviewing, and placement of high-level product development engineers.

We are seeking an individual to manage the full recruiting lifecycle: sourcing, screening, interviewing, reference checking, and negotiating employment terms. The candidate will be well versed in all aspects of professional recruiting, including networking and the recent trends in hiring.

Ideal candidates will be skilled in the use of applicant tracking systems and be self-sufficient in navigating and administering the applicant flow process.

Prefer BS degree, with proven track record of success in the staffing industry.

We offer excellent earning potential, a competitive benefit package, and an opportunity to be successful in the fast-paced, growing technical staffing industry.


 

Posted: September 6, 2018, 9:34 am
Category : Sales
Job Type : Permanent
Id : 7487
Region : Twin Cities

Development Resource Group is a growing Technical Staffing firm located in Mounds View, MN. Since 1986, DRG has been assisting clients in locating experienced engineers for project-based work on a temporary, contract-to-hire, or permanent basis. We specialize in placement of hardware, software, and mechanical engineering personnel with a strong base of high tech product development companies in the Twin Cities. Our engineers are responsible for design, programming, and testing for medical device products, electronic products, control products and automation systems.

We are seeking a motivated and energetic individual to add to our Sales Team as an Account Representative. Account Representatives are responsible for working with our clients in establishing their needs and then working with our recruiting staff to fill those needs. Additionally, they support all contracted staff though the duration of their project, working to ensure both client and contractor's satisfaction. Candidates must have excellent communication skills, a high level of computer systems knowledge, technical staffing experience, be self-motivated and enjoy working in the "people business." A college degree is preferred, with several years of staffing sales experience and/or recruiting experience in a Technical or Engineering field.

We offer an enjoyable working environment with a proven track record in our industry, excellent earning potential, a very competitive benefits package and an opportunity to be successful in the fast-paced, growing technical staffing profession.



Posted: September 6, 2018, 8:20 am