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Development Resource Group

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Category : Quality Engineer - Medical Device
Job Type : Contract
Id : 8267
Region : Twin Cities

The Sr. 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: April 12, 2021, 9:21 am
Category : Systems Engineer
Job Type : Contract
Id : 8266
Region : Twin Cities

Seeking a Systems Product Engineer for the following:

  • Perform product and device-oriented cybersecurity-related activities ranging from incident response to vulnerability assessments to mitigation implementation.
  • Conduct product risk assessments in conjunction with product R&D teams and develop and recommend specific security controls for product/system wide security needs.
  • Participate in the creation and testing of product security-related requirements and processes. Evaluate security risks on programs across the entire development lifecycle, including market-released product.
  • Ownership of security-related deliverables for regulatory bodies, ensuring compliance with key standards / guidance documents, and represent SI to those regulatory bodies
  • Contribute to company's understanding of current industry best practices and how they can be applied to SI Products.
  • Work under minimal consultative direction toward long range program goals and objectives.
  • Develops technical ideas and guides their development into final product.
  • Maintain a high level of technical knowledge on security.
  • Implementation of the Security Development Lifecycle across projects
  • Consistent implementation of the Quality System across projects
  • Create relationships and contracts with external vendors for security products, consultation, or other services

Qualifications - Must Have:

  • Bachelor's degree required Minimum of 7 years of relevant experience, or advanced degree with a minimum of 5 years relevant experience
  • Nice to Have 3+ years in critical Systems Security Engineering related roles or 5+ years of experience with a Master's Degree in a technical/engineering discipline including 3+ years in critical Systems Security Engineering related role
  • Broad experience with information and systems security.
  • Demonstrated leadership, team work skills and project management, including ability to create and track to broader goals and vision.
  • Demonstrated experience with Risk Management and Systems Engineering processes.
  • Demonstrated ability to develop and grow productive, trusting and open relationships with a wide variety of constituencies.
  • Demonstrated ability to lead and communicate across organizations and geographies in a crisp manner.
  • Demonstrated strong analytical, problem solving skills.
  • Proven record of working independently and understanding program goals
  • Experience in Healthcare industry or other heavily regulated industry.
  • In-depth understanding of system development lifecycle methodologies.
  • Design and implementation experience with security for: Embedded software & systems Capital equipment in a hospital setting Mobile applications, OS, cloud systems IoT Experience with Clinical IT and Clinical IT Security stakeholders In-depth medical device systems knowledge and experience Prior security design experience in critical industries such as DOD, DOE, NSA Specialized knowledge desired: Ethical hacking (certification preferred) Embedded devices Research and Development Relevant engineering processes and skills Security technologies and approaches Medical device technology Wireless communication systems.


Posted: April 12, 2021, 7:06 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 : Quality/Regulatory
Job Type : Contract
Id : 8263
Region : Twin Cities

A Risk Management Operations Quality Engineer assures new or modified products perform the functions intended in a safe manner and establishes compliance with the quality system. They collaborate with clinical, design engineering, regulatory, labeling, and post market surveillance functions to ensure that the PFMEA is appropriately mitigated, evaluated, disclosed, and monitored. They are 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.

Job Duties:

  • Execute and support on-time updates of PFMEA
  • Maintain PFMEA deliverables to ensure continued acceptability of product based on post market feedback
  • Support PFMEA updates including occurrence rating calculations
  • Support DHF content completion, integrity, and regulatory & standards compliance; collaboratively communicating & resolving gaps
  • Drive creation of risk mitigation strategy and support the establishment of objective, measurable, discrete, and verifiable customer and product requirements to meet that strategy.
  • Complete Document Change Request Reviews in a timely and objective manner
  • Additional duties may be identified by functional management based on the current project/business objectives.
  • Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
  • 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.
  • Performs other related duties and responsibilities, on occasion, as assigned.

Qualifications:

  • Bachelor level degree in Engineering or Technical Field, advance degree preferred
  • 2 - 4 years’ experience
  • Previous engineering experience preferred
  • Experience creating PFMEA
  • Solid communication and interpersonal skills
  • Experience working in a broader enterprise/cross-division business unit model preferred.
  • 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.
  • 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.
  • Ability to maintain regular and predictable attendance.


Posted: April 8, 2021, 12:40 pm
Category : Controls Engineer
Job Type : Contract
Id : 8262
Region : Twin Cities

The Industrial Controls Engineer role 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 engineer would also be involved in determining if existing equipment is adequate to support production manufacturing requirements for new products.

This engineer would be responsible for designing and implementing both the software and the hardware portion of the equipment solution. This development is accomplished by interfacing with manufacturing and process development engineers to create a compliant solution for production equipment release and support. 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. Utilizes software languages and environments including PLC Ladder Logic, LabVIEW, and/or structured text for the development and writing of code. Troubleshoots 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 software languages and environments preferably in PLC Ladder Logic, LabVIEW and/or structured text to perform application software development and electronics design
  • Designing, developing, and debugging dedicated hardware and software, performing verification and validation activities, performing Measurement Systems Analysis (Gage R&R studies); all in support of equipment solution release for production manufacturing of electronic medical device components
  • 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
  • Active and key participant in the evaluation and strategic planning for new: technology, products and materials and their impact on the business. Performs research and evaluates new ideas & technologies
  • Responsible for department budget as related to Annual Operating Plan targets.
  • Develops electromechanical technical solutions to complex problems that require the regular use of ingenuity and creativity
  • Lead and foster a culture of driving toward high quality designs, collaboration, and innovation
  • Mentors and serves as a both a people and technical leader
  • Work is performed with minimal direction
  • All activities must be performed in compliance with the Quality System.
  • Performs duties in compliance with environmental, health and safety related site rules, policies or governmental regulations
  • All other duties as assigned
  • Travel requirement: less than 10%

POSITION REQUIREMENTS:

  • Bachelors in Electrical Engineering, Controls Engineering, Industrial Engineering, Computer Engineering or related Engineering discipline
  • 5+ years of experience in Engineering Design and Development with Bachelor
  • 3+ years of experience in Engineering Design and Development with an Advanced degree
  • Software application development experience
  • PLC Ladder Logic, Structured text, Industrial Controls Software, HMI development experience
  • 3+ years of experience working in a medical or other regulated industry
  • Strong communication, manufacturing process, product industrialization and leadership skills
  • Solid design, troubleshooting and presentation skills


Posted: April 7, 2021, 12:43 pm
Category : R&D Engineer
Job Type : Contract
Id : 8261
Region : Twin Cities

Seeking a Sustaining R&D Engineer with 3+ years of related work experience with a complete understanding of specified functional area for a major medical device company.

Responsibilities include:

  • Provides R&D support for market-released cardiovascular catheters.
  • Conducts feasibility studies to verify capability and functionality to support investigations and/or design changes.
  • Develops solutions to improve product function and manufacturability.
  • Directs support personnel and coordinates project activities.
  • Write and submit Engineering Change orders.
  • Maintains detailed documentation throughout all phases of development.
  • Investigates and evaluates design changes, manufacturing changes, NCMRs, CAPAs and/or customer complaints.
  • Reviews or coordinates vendor activities to support development.
  • Research various cost-effective, alternative approaches to current designs and processes.

Requirements:

  • Prior medical device engineering experience in R&D preferred
  • Bachelor's degree in Mechanical, Biomedical or Electrical Engineering or an equivalent combination of education and work experience


Posted: April 7, 2021, 10:35 am
Category : Mechanical Engineer
Job Type : Contract
Id : 8259
Region : Twin Cities

Looking for a Senior Mechanical Engineer to join the R&D Organization to design and develop Medical Device systems.

Areas of responsibilities will include mechanical system design, design requirements, test requirements and test procedures. Candidates must be able to translate design inputs into mechanical options and concepts, write detailed mechanical specifications, generate and review design documentation, test specifications and test reports in compliance with design control procedures used within the medical device industry. Candidates must also be willing to work in a fast paced, multi-tasking, team environment.

POSITION RESPONSIBILITIES

  • The candidate must have the ability to work well with a variety of individuals ranging from the various engineering disciplines (mechanical, electrical, and software) to marketing, clinical, reliability, regulatory and operations.
  • Bring clarity and focus to the early stages of hardware development; ensuring design inputs are translated into hardware/system options.
  • Translate design input requirements into mechanical concepts, perform component/material selection, and create device and test specifications
  • Execute detailed thermodynamics, structural mechanics, and heat transfer calculations/simulations
  • Perform data analysis (statistical and practical) and develop appropriate action plans based upon such analysis.
  • Research and implement new technologies to enhance product features, improve reliability, and lower cost
  • Develop tooling and test equipment designs for product assembly and testing.
  • Review the designs of other engineers
  • Partner with manufacturing engineering to transfer new product designs to production
  • Work independently, in consultation with Engineering Management
  • Ensure design compliance with applicable standards such as IEC 60601-1, ISO 14971, 21CFR Part 820

BASIC QUALIFICATIONS/EDUCATION/EXPERIENCE

  • BS Mechanical Engineering
  • Minimum 6+ years experience in mechanical design of instruments/capital equipment
  • Strong knowledge of mechanical design using CAD tools, specifically SolidWorks
  • Proficient in mechanical drawing dimensioning and tolerancing per ASME Y14.5
  • Ability to create detailed designs, drawings, and specifications that effectively communicate design intent and acceptance criteria. This includes, but is not limited to, the following: Material selection and specification, Manufacturing process selection, Component specifications, Assembly drawings, Cable/wire harness drawings, DFX (design for reliability, manufacturability, serviceability, testability, etc.)
  • Must be able to review the work of other engineers
  • Must be able to work with minimal supervision
  • Ability to work in a team environment; strong collaboration skills
  • Effective verbal and written communication

DESIRED/PREFERRED QUALIFICATIONS

  • MS Mechanical Engineering
  • 5 or more years’ experience in medical device design
  • Sheet metal design experience
  • Plastic Injection molding design experience
  • Electronics enclosure design experience
  • Knowledge of engineering and manufacturing test equipment design and LabVIEW
  • Experience working with vendors and contract manufacturers for mechanical fabrication and assembly
  • Solid working knowledge of regulatory requirements for medical product development, including knowledge of federal and international regulations, such as FDA QSR, IEC 60601, ISO: 13485, 14971, 62304, and 13485, Medical Device Directive or other regulating agencies is strongly desired
  • Ability to troubleshoot complex electromechanical systems


Posted: April 6, 2021, 10:47 am
Category : Firmware Engineer
Job Type : Contract
Id : 8258
Region : Twin Cities

Looking for a Firmware Engineer II to join the R&D Organization to design and develop new and modifications to embedded firmware for medical device systems.

Areas of responsibilities will include firmware system design, software development in C, and design requirements and documentation.

Candidates must be able to translate design inputs into firmware design, write detailed firmware specifications, generate, and review design documentation, and interface specifications in compliance with design control procedures used within the medical device industry.  Candidates must also be willing to work in a fast paced, multi-tasking, team environment.

 

POSITION RESPONSIBILITIES

  • The candidate must have the ability to work well with a variety of individuals ranging from various engineering disciplines (mechanical, electrical, and software) to marketing, clinical, reliability, regulatory and operations.
  • Design, develop, test, document, operate and maintain software and firmware components and computing systems software to be applied to and integrated with mechanical and electrical systems.
  • Applies the appropriate standards, processes, procedures and tools throughout the system development life cycle to support the generation of such engineering applications and wide range of products.
  • Support Manufacturing in troubleshooting operations involving medical devices through assembly and test
  • Research and implement new technologies to enhance product features, improve reliability, and lower cost
  • Provide technical assistance to other functional departments such as Quality, Reliability, and Manufacturing
  • Work in an Agile environment as part of team, in consultation with Engineering Management

 

BASIC QUALIFICATIONS/EDUCATION/EXPERIENCE

  • 3+ years of embedded firmware/software design and development with Bachelors Degree in Engineering (Electrical or Software) or
  • 2+ years of experience with Masters Degree
  • Embedded firmware/software development in C language
  • Strong experience working with hardware, including ability to read schematics, data sheets and interface specifications
  • Strong experience developing and running unit tests using standard unit test frameworks
  • Strong experience in technical specification and report writing
  • Must be able to mentor and review the work of less experienced engineers
  • Must be able to work with minimal supervision
  • Mastery of basic laboratory instruments and tools (e.g. DMM, oscilloscope, logic analyzer, spectrum analyzer)
  • Ability to work in a team environment; strong collaboration skills
  • Effective verbal and written communication

 

DESIRED/PREFERRED QUALIFICATIONS

  • MS Software Engineering or Electrical Engineering
  • Experience with cardiac ablation products
  • Experience with ARM Cortex M processors (preferably STMicro)
  • Experience with real-time operating system (e.g. µC/OS-II, FreeRTOS)
  • Experience with IAR Embedded Workbench
  • Experience with TCP/IP communication and lwIP
  • Experience with Unity unit test framework
  • Experience with C#
  • Experience with embedded security (e.g. Secure boot, Chain of Trust, Authentication, etc.)
  • Specific knowledge of international medical device standards


Posted: April 6, 2021, 10:36 am
Category : R&D Engineer
Job Type : Contract
Id : 8257
Region : Twin Cities

The Sr. R&D Engineer designs, develops, analyzes, troubleshoots and provides technical skills during research and/or product development. Designs studies to investigate specific life science questions within field of expertise. May be involved in product research and development and/or clinical trials. Translates research discoveries into usable and marketable products.

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: April 5, 2021, 11:56 am
Category : Packaging Engineer
Job Type : Contract
Id : 8254
Region : Twin Cities

Seeking a Packaging Engineer II to manage and execute packaging changes to drive margin improvements, while ensuring current state performance, Specify, design, verify and validate packaging in accordance with applicable medical regulatory standards.

  • Develop packaging specifications, conduct pFMEAs, DOEs, validation protocols/reports and other associated documentation following design control requirements through completion.
  • Prepare Quality Plans, Design Change Plans, Master Validations Plans, protocol, and written reports.
  • Prepare technical reports, analysis, recommendations and presentations reflecting the status and results of projects in progress on a regular basis.
  • Evaluates process and design alternatives based on design for manufacturability principles.
  • Troubleshoots to determine optimal run ability of packaging.
  • Communicate effectively and participate on cross functional development teams.
  • Comply 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.

 

Experience:

  • Packaging specification development, Packaging testing for all types of packaging including cartons, corrugate, labels, pouches, thermoform trays, etc.
  • Development of qualification protocols for the medical device/pharma industry.
  • Experience in sterilization processes and protocols, Proficient in reading and creating engineering drawings, including dimensions, tolerances and schematics,
  • Excellent working knowledge of writing protocols, preparing testing samples, testing samples, and making strong conclusions.
  • Excellent firsthand working knowledge medical device package testing as well as proficient working knowledge of ASTM standards associated with medical device package testing.

 

Requirements:

  • Packaging Engineer by education/experience, BS in Packaging, Mechanical, or Manufacturing Engineering
  • 5-10 years packaging industry experience
  • 3-5 year in med device/pharma industry
  • Proficient and extensive working knowledge of packaging equipment for all related processes
  • Proficient and extensive working knowledge of packaging material and suppliers processes.
  • Subject matter expert of ISO 11607 part I & part II

 



Posted: April 5, 2021, 8:16 am
Category : Quality Engineering
Job Type : Contract
Id : 8253
Region : Twin Cities

Looking for a Quality Engineer to initiate medical device quality assurance activities for a major medical device company. These activities must be in accordance with FDA Quality System Regulation, ISO13485 and other international standards. This position will also support device complaint investigation and failure analysis as required.

Essential Duties and Responsibilities:

  • Develop incoming inspection processes and document incoming inspection activities.
  • Provide in-process QA support to include inspection and document review.
  • Complete final acceptance activities.
  • Manage the sterilization process, including validations and product sterile loads.
  • Track nonconforming material and lead Material Review Board (MRB) efforts.
  • Interface and take lead QA role in interactions with suppliers, contractors and consultants that supply components, subassemblies and contract processing.
  • Lead complaint investigations on returned product.
  • Manage corrective action and quality improvement activities.
  • Manage aspects of internal quality system relating to receiving inspection, calibration, MRB, etc.
  • Assist in the performance of quality system internal auditing.
  • Support quarterly management review meetings.
  • Establish, monitor and evaluate quality system metrics.



Posted: April 5, 2021, 8:10 am
Category : Manufacturing Engineer
Job Type : Contract
Id : 8252
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.).

 

Requirements:

  • Bachelor of Science in Engineering
  • 2-5 years engineering experience, prior medical device experience 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.
  • Ability to work within a team, and as an individual contributor in a fast-paced environment
  • Ability to leverage and/or engage others to accomplish tasks.
  • Multitasks, prioritizes, and meets deadlines in a timely manner.
  • Strong verbal and written communication skills with ability to effectively communicate at multiple levels in the organization.
  • Strong organizational skills and attention to detail.

 



Posted: April 5, 2021, 7:57 am
Category : Quality Engineering
Job Type : Contract
Id : 8251
Region : Twin Cities

The Design Assurance Engineer works closely with development/manufacturing/quality engineering to ensure compliance with the quality system. You will work closely with Regulatory Affairs personnel (internal or external) to monitor regulatory compliance. You will monitor quality assurance efforts to ensure that the company’s products conform to quality standards. You will partner with research/development and manufacturing engineering during new product start-ups and establishes checkpoints for testing new products and processes. The design assurance engineer is responsible for following established GMP/ISO compliant quality system practices.

Essential Functions:

  • Ensure company’s adherence to the established Quality System and GMP/ISO standards, including ongoing establishment and improvement to the quality system procedures.
  • Lead design assurance activities in support of development for electromechanical systems that utilize microcontroller technology, customized/off the shelf PCBs and software applications.
  • Manage new product Design History Files.
  • Work with Engineering, Marketing, Manufacturing and Regulatory to establish measurable, valid product requirements.
  • Aide in definition of test equipment as required to accomplish quality responsibilities.
  • Develops and documents test plan protocols, test procedures, and test reports.
  • Perform tests according to various protocol requirements. 8. Lead completion of risk management and risk analysis including FMEA.
  • Devise design verification and design validation plans for products based on performance specifications and risk analysis
  • Analyze and communicate conformance to specifications and standards.
  • Conducts technical and statistical investigations concerning compliance to specification and optimization of design relevant to specification.
  • Support completion of in vitro testing including applicable animal studies.
  • Aide in definition of supplier quality specifications, sampling plans, and vendor qualification.
  • Assist in specifications and testing of sterilization methods.
  • Lead system and product continuous improvement teams.
  • Reviews Engineering Change Orders, as required.
  • Perform other duties and responsibilities as assigned by senior management.


Posted: April 5, 2021, 7:51 am
Category : Software Engineering
Job Type : Contract
Id : 8250
Region : Twin Cities

As Staff 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.
  • Take ownership for 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 interactions
  • Manage System and subsystem requirements including definition, decomposition, analysis and traceability to ensure clear and unambiguous software requirements
  • Play 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 generation
  • Reviews software designs to ensure they implement the appropriate software behavior and requirements
  • Ensure that all activities conform to Quality and compliance requirements
  • As 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:

  • Bachelor’s Degree in Engineering (Computer, Electrical, Computer Systems, Systems, or Software), Computer Science, or related discipline
  • 6+ years of software engineering design and development or systems engineering experience
  • Demonstrated knowledge and experience working with C++
  • Experience with creating and managing requirements and translating them into effective architectures and software design
  • Excellent verbal and written communication skills, with ability to communicate to all levels of the organization

Preferred Qualifications:

  • Master’s Degree in Engineering (Computer, Electrical, Computer Systems, or Software), Computer Science, or related discipline
  • Knowledge of 62304 and other standards applicable to Class II and Class III medical devices
  • Previous experience working in a regulated industry such as automotive, aerospace, healthcare, or defense
  • Well versed in draft FDA Cybersecurity Guidance and GDPR
  • Demonstrated ability to provide technical leadership and mentorship
  • Experience with complex electromechanical systems including hardware, embedded firmware, disposables, and software
  • Academic GPA: 3.0 plus


Posted: April 5, 2021, 7:46 am
Category : Software Engineering
Job Type : Contract
Id : 8249
Region : Twin Cities

The Software Integration Engineer is a critical technical contributor to building compelling products within Electrophysiology. In this role, you will participate in the development and deployment of system and software architecture to support our development programs. Working with other integration engineers, you will be responsible for participating in the concept development, testing, and investigation of complex software applications which include signal processing, algorithms and visualization in a real-time environment. All this will happen in an environment which emphasizes a robust cybersecurity and patient privacy focus.

Primary Duties and Responsibilities

  • Contribute significantly to completion of various project activities, from definition, use cases, identifying software functional requirements, design, implementation, code reviews, and final release according to medical device development processes.
  • Work independently and with other engineers in the software team and cross-functionally to develop workflow tests and identify software defects prior to publishing the software build
  • Work closely with cross-function team, including design reviews with QA, RA, test engineers, hardware engineers to ensure the software & firmware design meets the product requirements, including safety, reliability and serviceability. Be creative and innovative in the product development process.
  • Make, recommend, or justify critical technical decisions in product design for complex systems. The decision should be based on broad investigation and testing.
  • Provide technical support and sustaining development in launch phase.
  • Lead and participate the software investigation process of products in the early launch phase including assessing, tracking, and documenting issue, root cause, and work arounds.
  • Support process improvements which guide the development, sustaining & support activities
  • Engage subject matter experts in successful transfer of domain knowledge
  • Proactively share information across the team, to the right audience with the appropriate level of detail and timelines
  • Familiarity with all aspects of Software Development Life Cycle and methodologies

Qualifications/Requirements

  • B.S. in Engineering or related discipline
  • 2+ years experience in R&D development environment
  • Passion for technology and willingness to learn
  • Desired Characteristics
  • 2+ years programming experience
  • 2+ years of Agile software development
  • Experience in software development in the medical field
  • C++, Linux, Jira, Windchill, Jenkins
  • Experience developing software emulators used to emulate hardware to enable software testing
  • Working knowledge of cardiac anatomy and electrophysiology
  • Personal Attributes
  • Strong oral and written communication skills
  • Strong interpersonal skills
  • Effective team building and problem-solving abilities
  • Persists to completion, especially in the face of overwhelming odds and setbacks. Pushes self for results; pushes others for results through team spirit



Posted: April 5, 2021, 7:34 am
Category : Quality Engineer - Medical Device
Job Type : Contract
Id : 8247
Region : Twin Cities

Seeking a Sr. Quality Engineer supporting new product development and design transfer activities. They are 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 lead and provide strategic direction on design for manufacturability, risk management evaluation as well as process validation.

This position provides support to the Manufacturing organization to facilitate efficient operations within the production area, to optimize existing processes, and to ensure that production goals are met. Monitors performance of equipment, machines and tools and corrects equipment problems or process parameters that produce non-conforming products, low yields or product quality issues.

Main Responsibilities:

  • Execute and support on-time completion of Design Control Deliverables
  • Accountable for Process Verification and Validation planning & execution, including active cross-functional root-cause analysis investigation & resolution activities
  • Lead or support Risk Management activities from product Development through Commercialization
  • Support design and manufacturing test and inspection method development, and lead method validation activities
  • Ensure DHF content completion, integrity, and regulatory & standards compliance; collaboratively communicating & resolving gaps
  • Responsible for compliance with applicable Corporate and Divisional Policies and procedures.
  • Leads technical activities for new or improved products or process, for current programs, next generation programs and to meet strategic goals and objectives of the company.
  • Presents findings and recommendations.
  • Analyzes and solves problems from basic engineering principles, theories and concepts through to a wide range of complex and advanced problems which require novel and new innovative approaches or a major breakthrough in technology.


Posted: March 31, 2021, 12:24 pm
Category : Software Engineering
Job Type : Contract
Id : 8246
Region : Twin Cities

Seeking a Sr. Software Engineer to be a critical contributor to building compelling products for a major medical device company. The individual will participate the development and deployment of system and software architecture to support our development programs. Design, develop, and document software applications embedded in diagnostic and interventional cardiology devices. Participate in all phases of the software lifecycle, including concept development, requirements, design, implementation, and testing.

Primary Duties and Responsibilities

  • Apply solid software design skills to develop medical devices to meet specific performance requirements and deliver on goals according to product development quality system. These activities include developing requirements specifications, design, implementation and testing of software and embedded software algorithms or/and general Linux applications and GUIs.
  • As a team member, contribute significantly to completion of various project activities, from definition, identifying software functional requirements, implementation, code reviews, and final release according to medical device development processes.
  • Create and implement software/test plans/protocols and generate test reports to ensure software/firmware design meets the specifications and quality system requirements.
  • Work closely with cross-function team, including design reviews with QA, RA, test engineers, hardware engineers to ensure the firmware design meets the product requirements, including safety, reliability and serviceability. Be creative and innovative in the product development process.
  • Make, recommend or justify critical technical decisions in product design. The decision should be based on broad investigation and testing.
  • Document and transfer developed solutions to manufacturing team for mass production and provide technical support and sustaining development in launch phase.

Minimum Requirements:

  • B.S. or M.S (Preferred) in discipline such as Computer Engineering, Computer Science, Electrical Engineering, Computer Systems Engineering, Software Engineering.
  • 6+ years of software engineering design
  • Experience with creating and managing requirements and translating them into effective architectures and software design
  • An understanding of requirements for, and experience in medical device development
  • Excellent documentation skills (highly regulated development environment)
  • Excellent C++/C# knowledge
  • Operating Systems: Linux
  • Software development through full product life-cycle

Preferred Qualifications:

  • Medical device development experience and IEC60601-1, IEC62304 and related IEC standard familiarity preferred.
  • Development/Process Tools: MS Visual Studio, Jira, Perforce
  • Experience developing robust software applications that address Cyber Security concerns
  • GUI development experience: Qt/QML
  • Windows 10/IoT,
  • Experience with distributed embedded systems


Posted: March 31, 2021, 8:11 am
Category : Quality Engineering
Job Type : Contract
Id : 8245
Region : Twin Cities

Seeking a Quality Engineer to develop, modify, apply and maintain quality standards and protocol for processing materials into partially finished or finished materials product.

Collaborate with engineering and manufacturing functions to ensure quality standards are in place.

Devise and implement methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment.

Design or specify 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.

Ensure 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.

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



Posted: March 30, 2021, 12:13 pm
Category : Reliability Engineer
Job Type : Contract
Id : 8244
Region : Twin Cities

Seeking a Reliability Engineer to develop, coordinate and conduct technical reliability studies and evaluations of engineering design concepts and design of experiments (DOE) constructs.Recommend 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.Compile and analyze performance reports and process control statistics; investigates and analyzes relevant variables potentially affecting product and processes.Ensure that corrective measures meet acceptable reliability standards.Analyze 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.Requires a University Degree and minimum of 2 years of relevant experience, or advanced degree with 0 years of experience.

Posted: March 30, 2021, 11:57 am
Category : Reliability Engineer
Job Type : Contract
Id : 8243
Region : Twin Cities

Seeking a Sr. Reliability Engineer to develop, coordinate and conduct technical reliability studies and evaluations of engineering design concepts and design of experiments (DOE) constructs.Recommend 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.Compile and analyze performance reports and process control statistics; investigate and analyze relevant variables potentially affecting product and processes.Ensure that corrective measures meet acceptable reliability standards.Analyze preliminary plans and develop 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 specify minimum number of samples to obtain statistically valid data.Deliver and/or manage 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).Be able to work independently under limited supervision to determine and develop approach to solutions.Coach and review the work of lower level specialists; may manage projects / processes.Make 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.Communicate with senior internal and external customers and vendors.Exchange information of facts, statuses, ideas and issues to achieve objective, and influence decision making.Requires a University Degree and minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience.

Posted: March 30, 2021, 11:44 am
Category : Quality/Regulatory
Job Type : Contract
Id : 8242
Region : Twin Cities

Seeking a Principal Quality Engineer with Experience/knowledge of manufacturing processes used to build medical device products such as machining, metal forming, injection molding, plastic extrusion, sub- assembly, packaging, stamping. The ideal candidate will also have experience/knowledge of process risk assessment such as pFMEA or similar, or process solving methodologies such as PDCA, DMAIC using standard problem solving tools such as Cause and Effect diagrams, 5 Why, process flow charts, pare to and trend charting.  This engineer should also have the ability to influence engineering/technical peers from cross functional teams to support improvement project deliverables per establish improvement plans OR through a CAPA process system. In a nutshell; looking for an autonomous problem solver

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

  • 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.
  • An individual contributor with responsibility in our technical functions to advance existing technology or introduce new technology and therapies. Formulates, 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 R&D, systems or initiatives related to new technologies or therapies – from design to implementation - while adhering to policies, using specialized knowledge and skills.
  • 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 Baccalaureate degree (or for degrees earned outside of the United States, a degree which satisfies the requirements of 8 C.F.R. • 214.2(h)( 4)(iii)(A) and minimum 7 years of relevant experience, or advanced degree with a minimum of 5 years of relevant experience.


Posted: March 30, 2021, 8:38 am
Category : Project Manager
Job Type : Contract
Id : 8241
Region : Twin Cities

Seeking an experienced innovative Program Manager, forward thinking leader looking for a leadership opportunity. Do you have a passion for Med Device development and want to improve patients’ lives? Can you help customers accelerate their time to take a product to market?Looking to lead, innovate and challenge?

Successful candidates for this role have experience taking new medical devices to market. You will have leadership and critical thinking skills, allowing you to develop business advisory relationships with customers. Successful Program Managers add value by using their knowledge to solve problems, proposing technical solutions and providing project management services to accelerate their time to market.

To be considered for this opportunity, you must have a Bachelor’s Degree (Software, Electrical, Mechanical or Systems Engineering preferred); Minimum of 5+ years’ experience in Med Device development, including program management and engineering.; Experienced with design and documentation controls, and developing medical products in an ISO 13485 certified quality system.

Position Responsibilities:

  • Challenge assumptions and become a solution resource to reduce development risk and accelerate time to market.
  • Partner with Business Development and Systems Engineering, to develop estimates and proposals for new business opportunities.
  • Lead and participate in the identification and documentation of product requirements, innovative design solutions and scalable manufacturing processes
  • Innovate and gain experience with a range of clinical applications and unique technologies
  • Work with a team of talented engineering professionals to offer innovative design solutions and design for manufacturability to bring devices to market efficiently and effectively
  • Ensure optimal engineering solutions and sound manufacturing processes are implemented within budget and schedule


Posted: March 29, 2021, 2:10 pm
Category : Mechanical Engineer
Job Type : Contract
Id : 8240
Region : Twin Cities

Seeking a Human Factors Design Engineer to apply knowledge of human performance (perceptual, cognitive and motor skills) and human factors techniques to identify user needs, develop requirements, and inform/contribute to design across the product development cycle. Activities will include: field research to identify user needs and work flows; task analysis; software and hardware user interface design; conducting usability tests; data analysis; communicate research outcomes to key stakeholders; and risk assessment.

Position responsibilities under the guidance of HFE Lead:

  • Conduct field studies/literature reviews/research and apply the outcomes to requirements definition, concept development, and detailed design.
  • Work closely with marketing, product planning, engineering, manufacturing, quality assurance, technical communications, and regulatory to produce design solutions that meet user needs and consider business needs and manufacturing constraints.
  • Contribute to the development of physical mock-ups and interactive prototypes of design concepts.
  • Plan and conduct usability tests of product concepts; analyze data; document evaluation methods and results; and present design recommendations to the product development team.
  • Full-time (40-hour/week) time availability.
  • Able to travel globally to support project needs as required.

Position Requirements:

  • Bachelor’s Degree in human factors-related discipline
  • 3+ years of experience with Bachelors Degree; or 1+ years of experience with Masters Degree; or 0+ years of experience with PhD candidacy (All But Dissertation).
  • Advanced knowledge in human physical and psychological capabilities and limitations, and methods used to study them.
  • Experience planning and conducting human subjects research studies, analyzing data, and reporting results verbally and in writing

Preferred Qualifications:

  • Graduate degree in human factors-related discipline
  • Graduate degree in Human Factors, Kinesiology, Psychology, Industrial Design, or a related field.
  • Be familiar with regulatory and industry requirements for Human Factors in medical device development.
  • Experience designing in a regulated technical (preferably medical device) environment.
  • Expert with Microsoft Office Suite
  • Experience designing with Adobe Design Suite
  • 3D CAD concepting and printing
  • Data visualization
  • Video production
  • Systems Engineering


Posted: March 26, 2021, 10:59 am
Category : Quality/Regulatory
Job Type : Contract
Id : 8239
Region : Twin Cities

Looking for a dynamic and adaptive Safety and Reliability Engineer with the desire to be part of proving and improving implantable medical products and supporting instruments, helping to ensure they exceed the safety and reliability requirements and expectations of patients, clinicians, regulators, and the business. As an integral member of project teams, working in collaboration with functional and cross-functional partners, you will be responsible for planning and leading product safety and reliability technical assessments and compliance activities to ensure that reliability and safety is proactively designed into products, that potential risks are analyzed and controlled, and that product/system performance is quantifiably predicted. Your work will span the product development lifecycle from research & technology, through development and early market release of new and derivative products.

A Day in the Life:

  • Contribute to the successful completion of major projects/programs
  • Provide imaginative, thorough and practical technical solutions to a wide range of problems, consistent with organizational objectives
  • Participate on cross-functional initiatives and teams, advocating for Quality
  • Develop and implement technical analyses, methods, and procedures, to drive product safety, reliability, and quality
  • Complete risk analysis of new design and processes, specifically planning, leading, executing, and integrating Risk Management activities to demonstrate product safety
  • Plan, lead, execute, and integrate Design for Reliability (DfR) activities, including coordinating and conducting technical reliability studies, to quantify product reliability
  • Plan, lead, execute, and integrate test and assessment activities, to demonstrate product performance and compliance
  • Recommend and apply statistical methods for analyzing data
  • Ensure that corrective measures meet reliability requirements and participate in preparing clinical evidence to demonstrate sufficient benefits to justify product risks
  • Concisely articulate risk management and reliability activities and conclusions in regulatory submissions and audits
  • Seek and propose ways to improve design reliability and process capability based on company metrics
  • Gain and apply thorough knowledge in US and foreign governmental regulations, agency guidelines, requirements, specifications, internal/corporate policies and required quality and reliability practices in assigned area
  • Ensure adherence to the business Quality Management System through procedure compliance and internal audits
  • Perform engineering reviews of quality records for compliance with stated requirements and impact on safety and reliability

Must Have - Minimum Requirements:

  • Bachelor’s Degree in Engineering, Science or technical field with 2+ years of work experience in Engineering and/or Quality OR Advanced Degree in Engineering, Science or technical field with 0+ years of work experience in Engineering and/or Quality.

Nice to Have:

  • Ability to convert to full-time employee upon contract completion
  • Experience working on multi-disciplinary teams Proficient in word processing, spreadsheets, and managing electronic data files
  • Advanced degree in Engineering or Science
  • Degree in Electrical Engineering, Biomedical Engineering, or Physics
  • Experience in Safety Engineering, Reliability/Quality Engineering, Systems Engineering, Product Development Engineering, Clinical, or Field Support
  • Proven understanding of reliability engineering principles
  • Ability to comprehensively apply degree-specific engineering principles in the design of highly reliable, complex systems
  • Strong understanding of and experience in the application of statistics, including experience with Minitab
  • Experience in a highly-regulated industry, preferably implantable medical devices
  • Understanding of implanted medical systems, products, therapies, and their use in the clinical environment, including customer expectations, common medical practice, and systems troubleshooting
  • Knowledge of cardiac anatomy, physiology, and primary disease states
  • Experience with 21 CFR Part 820 (Quality System Regulation), ISO 13485, etc.
  • Experience interpreting and applying industry standards (EN 45502/ISO 14708, IEC 60601, etc.)
  • Experience in the application of Risk Management (ISO 14971) and hazard analysis and risk analysis techniques (e.g., PHA, HA, FTA, DFMEA)
  • Ability to independently lead investigations to identify system/product failures, hazards, hazardous situations, and harms
  • IBHRE Certified EP Specialist (Allied Professional) and/or CRE Certified
  • Exposure to or experience working in or with Design, Quality, Regulatory, Clinical and/or Manufacturing
  • Knowledge of Design for Reliability (DfR), Design for Reliability and Manufacturability (DRM), Design for Six Sigma (DFSS), Design for Lean Sigma (DFLS), and/or robust design practices


Posted: March 26, 2021, 8:02 am
Category : Quality Engineering
Job Type : Contract
Id : 8238
Region : Twin Cities

We are seeking a Senior Development Quality Engineer to join our SH team in either our Saint Paul, MN or Plymouth, MN location. 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.

Primary Duties and Responsibilities:

  • 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 Risk Management activities, including analyzing field data to support new product development, and supporting Failure Mode Effects 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.
  • Develop and lead other team members.
  • 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
  • 5-8+ 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: March 26, 2021, 6:58 am
Category : Mechanical Engineer
Job Type : Permanent
Id : 8237
Region : Twin Cities

Seeking a Senior Mechanical Design Engineer to be responsible for innovation and product design management. This Engineer will also have the responsibility for taking a product through the whole design process. See your designs come to life.

 

The ideal candidate will have 5+ years of experience in outdoor power equipment industry; 4-yr degree in Mechanical Engineering or Ag Engineering Degree; Experience with commercial equipment used in outside environment, Solid Works computer system, project management, and experience developing from concept/prototype/testing/manufacturing release.  Hydraulic experience preferred.

 

This position is fully accountable for designing and developing new products, redesigning existing products, overseeing the prototype delivery, and testing of products that meet the schedule, costs, and performance specification of customers.

 

Position Responsibilities:

  • Develop mechanical designs of products using Solidworks
  • Research, design, evaluate, mechanical products, equipment, systems to meet project scope
  • 2+ years 3D modeling experience using Solidworks including the ability to create and work within large assemblies.
  • Work closely, and in partnership, with management team to ensure that all customer needs are anticipated and met.
  • Ability to produce product assembly drawings in Solidworks or similar
  • Experience creating detailed part drawings
  • Ability to develop engineering bills of materials
  • Need to have the ability to take a concept to final project
  • Must have design for manufacturability skills
  • Must be able to predict task time requirements and meet deadlines
  • Ability to develop test methods and design manufacturing fixtures
  • Willingness to do hands on type work and other tasks as necessary
  • Familiarity with Microsoft Office products a plus.


Posted: March 26, 2021, 6:27 am
Category : R&D Engineer
Job Type : Contract
Id : 8236
Region : Twin Cities

The Associate R&D Engineer designs, develops, analyzes, troubleshoots and provides technical skills during research and/or product development. Designs studies to investigate specific life science questions within field of expertise. May be involved in product research and development and/or clinical trials. Translates research discoveries into usable and marketable products.

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.
  • Required Knowledge and Experience: Requires broad theoretical job knowledge typically obtained through advanced education. Requires a University Degree, 0 years of experience required.



Posted: March 25, 2021, 11:13 am
Category : Test Engr - Technical
Job Type : Contract
Id : 8235
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: March 25, 2021, 11:03 am
Category : BioMedical Engineer
Job Type : Contract
Id : 8232
Region : Twin Cities

Seeking a Biomedical Research Engineer to be responsible for evaluations and development of novel cardiac catheters and mapping software to efficiently visualize and respond to pathophysiology. Under the direction of a senior scientist, the candidate will plan and execute experiments to help test prototype medical devices, process data, compute statistics, and write summary reports/presentations. The work will include opportunities to develop original ideas, create intellectual property, and conduct evaluations in benchtop and preclinical environments. Evaluate electrogram signal quality, impedance and magnetic localization, and characterize electrophysiology. The candidate will help coordinate efforts of different R&D groups including Catheter Development, Software Engineering, and Applied Research as well as interact with Human Factors Engineering and Marketing.

Required Experience:

  • A technical degree: BS or higher, with appreciation of math, science, and engineering concepts.
  • Experience in a high-level programming language for signal processing, data analysis, and visualization such as MATLAB or Python.
  • Basic familiarity with statistics software such as Minitab or JMP.
  • Basic experience with Linux OS, including the ability to navigate the file system and use basic commands.
  • Strong written and verbal communication skills with office software.
  • Interest and motivation to learn, develop products, and advance the state of the art in health care.

Desirable experience includes:

  • Cardiac electrophysiology, anatomy, and common arrhythmias
  • Digital signal analysis and linear algebra fundamentals
  • Familiarity with cardiac catheters
  • Design of Experiments
  • Geometrical/spatial reasoning and associated visualization software


Posted: March 25, 2021, 9:06 am
Category : Packaging Engineer
Job Type : Contract
Id : 8231
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: March 25, 2021, 6:41 am
Category : Manufacturing Engineer
Job Type : Contract
Id : 8230
Region : Twin Cities

The Sr. Manufacturing Engineer designs manufacturing processes, procedures and production layouts for assemblies, equipment installation, processing, machining and material handling. Designs arrangement of machines 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: March 25, 2021, 6:33 am
Category : Systems Engineer
Job Type : Contract
Id : 8229
Region : Twin Cities

The Sr. 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: 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: March 25, 2021, 6:27 am
Category : Controls Engineer
Job Type : Contract
Id : 8228
Region : Twin Cities

Excellent opportunity for a Controls Automation Engineer to support design and programming of manufacturing / test equipment used in the development and production of medical device products. Requires BS degree (EE, CS) and experience in design and programming of complex industrial machine control systems. This includes PLC / HMI programming, control panel / hardware design, and system troubleshooting and start-up.

  • Prefer 3 - 5 years of experience in automated system design.
  • Prefer experience with Allen Bradley/Rockwell Automation PLC and HMI, robotics, motion control, vision systems (Cognex) programming, and system validation and start-up.
  • Prefer experience with SAP and Manufacturing Execution Systems (MES).
  • Prefer experience working within an FDA (or similar) regulated validation and documentation process preferred, and experience with Visual Basic / .NET programming and SQL database development is a plus.


Posted: March 24, 2021, 6:45 am
Category : Quality/Regulatory
Job Type : Permanent
Id : 8225
Region : Twin Cities

Seeking a Senior Quality Engineer to provide quality and reliability support for all products for new product development, manufacturing and supplier operations. Key inputs will be to the risk management, design validation, supplier and component qualification, and process qualification/validation processes. Disposition of nonconforming materials and devices. Assist in addressing field issues, CAPAs, complaints, and clinical adverse events, as appropriate.

KEY DUTIES AND RESPONSIBILITIES:

  • Provide quality and reliability support for new hardware, firmware, and software product development projects.
  • Provide leadership for risk management activities such as reliability analysis, risk and hazard assessment, failure mode effects analysis, hazard analysis, and fault tree analysis.
  • Provide input on compliance with regulations and standards in the areas of quality systems, risk management, medical device software development, wireless coexistence, usability, and cybersecurity with responsibilities for generating and maintaining regulatory requirements documentation.
  • Provide input or generation, review, and approval of design and development documentation, protocols and reports for product hardware, software and firmware.
  • Plan, perform, coordinate, and/or oversee design validation testing and reporting for product hardware, software and firmware.
  • Review Test Plans and associated Test Reports for production and qualification screens and tests.
  • Provide quality and reliability support of manufacturing operations
  • Provide leadership for process failure mode effects analysis.
  • Provide input or generation and review of process evaluations, characterizations, qualifications, and validations.
  • Plan, perform, coordinate, and oversee supplier and component selection and qualification.
  • Perform, review and approve equipment selection and qualification activities as required.
  • Provide statistical analysis and sample size inputs to production and development qualification/validation testing and data.
  • Provide ownership or oversight to specific corrective and preventive action issues, as assigned.
  • Provide disposition of nonconforming materials, products, product holds, and deviations.
  • Assist in the investigation of returned products, field issues, complaints, and clinical adverse events with respect to root cause analysis, potential health risks, and corrective and preventive action activities, including health hazard analysis.
  • Develop and maintain non-product software items related to receiving, incoming inspection, and calibration. Software items use Visual Basic and other programming languages as required.
  • Perform code review of non-product software items related to field support, manufacturing, and development. SW/FW items use C, C#, Visual Basic and other programming languages as required.
  • Perform and lead internal audits for compliance to regulations and Company SOPs.
  • Oversee internal calibration activities, ensuring that all necessary equipment is properly calibrated and labeled for its intended use.
  • Serve as the Bloodborne Pathogen Coordinator ensuring proper training and ongoing review and implementation of these procedures.
  • Develop and implement strategies for the continuous improvement of the quality functions for which the position is responsible.
  • Plan, perform, or assist with Gage R&R studies of equipment.
  • Perform miscellaneous duties as assigned.

POSITION REQUIREMENTS:

  • BS Degree in Science or Engineering or technical equivalent plus 5 years or more experience in a medical device company.
  • Knowledge of FDA QSR and ISO 13485 regulatory requirements, guidelines and standards that pertain to medical devices. Knowledge of additional international regulations, radio equipment regulations, and risk management and cybersecurity standards is a plus.
  • Class III implantable medical device experience. Active implantable experience is a plus.
  • Ability to interface with internal and external customers in all aspects of the product life cycle.
  • Ability to apply statistics to solve problems and determine sampling plans.
  • Experience with risk and hazard analysis.

PREFERRED QUALIFICATIONS:

  • Education or experience in electrical engineering or electronics with software experience.
  • Proven communication, analytical, organizational, and problem solving skills.
  • Ability to participate in or lead internal and supplier audits.


Posted: March 19, 2021, 9:17 am
Category : Test Engr - Technical
Job Type : Contract
Id : 8222
Region : Twin Cities

As a Software E2E Test Engineer II, you will be responsible for the verification of medical device software products for a major medical device company. Candidate will be responsible for ensuring the implementation meets the business and system needs as well as ensuring overall product quality and quality deliverables for the test organization based on the defined Quality Management System. The E2E Test team is responsible for software product integration and verifying the entire system of devices and products.

This position will be responsible for the development and execution of both automated and manual test designs/protocols per verification software requirements in the medical device space.

Tasks include:

  • Working closely with Product Teams, Developers and Systems Engineers to fully understand the architecture and design of feature functionality and design test strategies to fully exercise functionalities and assure behaviors and performance across product interfaces.
  • Leverage technical experience and knowledge to break down high-level requirements to design test and automation strategies, and independently complete test development and executions per the defined processes and schedule to meet and exceed all customer expectations.
  • Leverage technical experience and knowledge to independently complete test development and execution activities per processes to exceed all quality expectations.
  • Design and Support best in class test infrastructure and test tools in support of software development processes, including development of automated scripts for testing inter-connectivity with IT/HR (Information Technology and Human Resource) based systems.
  • Work closely with Global IT and System Validation teams to ensure overall coverage and coordination on environment setup and execution
  • Drive and ensure the accuracy of software requirements with the System Engineering team.
  • Make sound independent technical decisions related to product quality and organizational performance to achieve maximized outcomes.
  • Drive overall metric and reporting capabilities to accurately summarize and report on product quality.

Must Have: Minimum Qualifications

  • B.S. in Computer Science, Computer Engineering, or related field
  • 2+ years of professional testing or development experience with a sound understanding of automation framework and test scripting and testing principles
  • Experience in Functional or Integration Testing of software products across various operating systems.
  • Hands on experience with Test Management and Defect Management tools preferably Azure Devops
  • Software development experience in either Test Automation & Frameworks or product software applications. Prefer Python, C#, VB Script or Java Script
  • Strong organization, communication, and presentation skills, able to articulate concisely & clearly and present in front of all levels of the organization.

Nice to Have:

  • MS in Computer Science, Computer Engineering, or related field with appropriate computer science course work
  • Ability to thrive and deliver on a team of verification engineers, software engineers and with cross-functional teams of system engineers, human factors, quality and offshore teams.
  • Prior Design/test/development experience with FDA controlled medical devices.
  • Experience working within a regulated environment.
  • Ability to learn emerging technologies in mobile space and perform innovative thinking in Mobile application testing
  • Experience with modern software engineering concepts, the software life cycle, and application software development using a variety of technologies
  • Ability to work in a team environment
  • Demonstrated proficiency in written and verbal communications



Posted: March 18, 2021, 6:34 am
Category : Quality/Regulatory
Job Type : Contract
Id : 8219
Region : Twin Cities

The Senior Materials Engineer will develop and execute the materials science and hazardous substances analysis of medical device products, supporting the regulatory submission of both implantable and non-implantable Company products. This individual will also support biological evaluations by completing deliverables like the TUV biocompatibility checklist. This person will work under general supervision, assembling current design documentation, providing gap assessments and strategies to remediate in accordance with international standards and European medical device regulations (e.g. RoHS, EU MDR, and California Prop. 65).

Position Responsibilities:

  • Analyzes and researches materials used in existing product designs and their related fabrication and application processes.
  • Applies principles of chemistry, physics, and material behavior to develop metallic, polymer, and composite material and processing specifications, fabrication and assembly processes.
  • Develops, analyzes and applies material properties and design, processing 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.
  • 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).

Differentiating Factors:

  • Knowledge of materials and interactions with the body and environment.
  • Knowledge of international and domestic regulations associated with biocompatibility and Hazardous Substances.
  • Experience in a regulated industry.
  • Materials Science knowledge with an emphasis on materials testing, processing, manufacturing and analysis.
  • Autonomy: Seasoned individual contributor. Works independently under limited supervision to determine and develop approach to solutions. 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.
  • Experience: Requires a University Degree in Materials Science, Chemical Engineering, or Biomedical Engineering and minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience.

DESIRED/PREFERRED QUALIFICATIONS:

  • Experience in regulatory and device regulations for medical devices including biocompatibility and regulated materials
  • Effective verbal and written communication skills
  • Ability to work well in a team environment
  • The ability to work well under pressure
  • The ability to evaluate, prioritize and manage multiple activities
  • The flexibility to adjust work objectives to ensure the overall goals are met
  • Demonstrated problem solving and critical thinking skills
  • Technical understanding of the effect processing has on material properties and performance
  • Ability to correlate material properties with product performance and predict various failure modes


Posted: March 16, 2021, 6:33 am
Category : Systems Engineer
Job Type : Contract
Id : 8218
Region : Twin Cities

We are looking for a high caliber Sr. Systems Engineer that will support design, development and test for next generation Electrophysiology Medical Systems for Navigation, Mapping and Ablation.

Responsibilities include:

  • Execute on-time completion of systems engineering deliverables
  • Lead concepts of operation reviews and updates to meet end user needs.
  • Develop systems engineering process flows to integrate system, software and hardware changes and updates
  • Development and analysis of system requirements
  • Lead and coordinate multiple engineering discipline teams
  • Lead project initiatives through planning and milestones
  • Development of system architectures and specifications
  • Conduct subsystem integration.
  • Problem documentation and resolution.
  • Ability to work independently with minimal/no supervision
  • Maintain high standards for content completion, integrity, and regulatory & standards compliance
  • Comply with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, company policies, operating procedures, processes, and task assignments.
  • Maintain positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors
  • Perform other duties and responsibilities as assigned by functional management based on the current project/business objectives including 10% travel, including international travel and regular predictable attendance.

Qualifications and Education:

  • 5+ years experience in R&D
  • Bachelor level degree in an Engineering Discipline
  • Project management experience
  • Team leadership experience

Preferred Qualifications and Education:

  • 2 years Systems Engineering experience
  • Advanced (Masters) degree
  • Degree in Systems, Electrical, Software or Biomedical Engineering


Posted: March 15, 2021, 11:54 am
Category : Test Engr - Technical
Job Type : Contract
Id : 8217
Region : Twin Cities

The Product Security Penetration Tester designs, develops, and implements product security testing methods. Plans, arranges, and executes penetration testing on medical devices. Compiles testing data and defines recommendations for how to make products more secure.

Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers projects assigned and works with other stakeholders to achieve desired results. The majority of time is spent delivering the projects from design of testing steps to execution of those tests and documenting results. This includes explaining technical testing results to non-technical team members.

  • Autonomy: Established and productive individual contributor. Works independently with general supervision on larger, moderately complex projects / assignments. 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. Recommends enhancements in systems and processes to solve security problems.
  • 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.
  • Required Knowledge and Experience: Requires practical knowledge and demonstrated competence within security 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.

Other tasks include:

  • Employ a variety of test methods to perform comprehensive vulnerability assessment and penetration testing of products
  • Leverage attacker like” testing techniques against products
  • Document and communicate the results of testing to relevant stakeholders
  • Coordinate with Development and Product Support teams
  • Leverage existing tools a develop a more robust Security Testing Program
  • Maintain awareness of existing and emerging medical device security research and leverage that knowledge during internal testing activities
  • Understand current FDA policies surrounding cybersecurity and utilize that knowledge to inform testing activities.
  • Identify opportunities for product security enhancement
  • Show creativity and innovation in all aspects of your responsibilities
  • Own your own training and development to ensure skills are in line with project needs
  • Participate on ad hoc Product Security Office Projects, as needed


Posted: March 15, 2021, 8:24 am
Category : Project Manager
Job Type : Contract
Id : 8215
Region : Twin Cities

The Engineering Project Manager plans, directs and implements all aspects of the company's design and development of new 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. Guides the conceptualization of new methodologies, materials, machines, processes or products. Directs the development of new concepts from initial design to market release. Manages feasibility studies of the design to determine if capable of functioning as intended. Monitors documentation maintenance throughout all phases of research and development. 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.

Management and supervisory professionals with one or more employees who are focused on tactical, operational and some strategic activities within a specified area. Levels within the management career stream typically have six or more direct reports. The majority of time is spent overseeing their area of responsibility, managing performance, developing talent, engagement and inclusion, communicating business and operational developments, planning, prioritizing and / or directing the responsibilities of direct reports. Goal achievement is typically accomplished through performance of direct and / or indirect reports. A key responsibility of roles in this career stream is managing people. which includes: accountability for mentoring, developing and coaching staff on meeting/exceeding performance expectations and defined objectives, providing leadership to staff ensuring the prioritization of strategic and department level initiatives to include defining performance goals and targets, conducting performance reviews, and staff 1:1s to guide performance management and employee development efforts and manage toward departmental goals.

  • Autonomy: Manages subordinate supervisors and/or experienced professionals who exercise latitude and independence in assignments. Provides tactical and / or operational leadership and coaching. Receives assignments in task and objective oriented terms.
  • Organizational Impact: Establishes operational plans and implements policies and strategies. Decisions impact program schedules, customer satisfaction levels, or allocation of time, material resources, expenditures and funds. May have budget or P&L accountability for a department, function or geography. 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 ongoing operations. 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 a team consisting of supervisors and / or experienced professionals in the Specialist career stream. Leads, directs and reviews the work of a team who exercise latitude and independence in their assignments. Authorizes hiring, firing, promotion and reward within own area.
  • 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 a specific technical or professional discipline 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: March 11, 2021, 6:51 am
Category : Quality/Regulatory
Job Type : Contract
Id : 8214
Region : Twin Cities

Seeking a Design Assurance Engineer to assure new or modified products conform to quality standards, establishes compliance with the quality system and assure compliance to MDR, as well as other geographical regulations. 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.

Main Responsibilities:

  • Ensure DHF content completion, integrity, and regulatory & standards compliance; collaboratively communicating & resolving gaps in support of MDR.
  • Execute and support on-time completion of Design Control Deliverables to support MDR.
  • Support 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 & execution of hardware and/or systems containing software, including active cross-functional root-cause analysis investigation & resolution activities.
  • Lead or support Risk Management activities from product Concept through Commercialization.
  • Support design test and inspection method development, and lead method validation activities.
  • Support manufacturing process development & qualification for new product commercialization and product changes.
  • Support internal & external audit responses.
  • Support product re-certifications.
  • Support the establishment of objective, measurable, discrete, and verifiable customer and product requirements.
  • Support objective component specification definitions, supplied component sampling plan development, and vendor qualifications.
  • Support execution of biocompatibility and sterilization qualifications.
  • Complete Document Change Request Reviews in a timely and objective manner.
  • Additional duties may be identified by functional management based on the current project/business objectives.
  • Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
  • 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.

Experience / Background:

  • Experience working in a broader enterprise/cross-division medical device business unit model preferred. Defense or other regulated businesses may be acceptable.
  • 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.
  • 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: March 10, 2021, 1:21 pm
Category : Quality/Regulatory
Job Type : Contract
Id : 8213
Region : Twin Cities

Seeking a Design Assurance Engineer to assure new or modified products conform to quality standards, establishes compliance with the quality system and assure compliance to MDR, as well as other geographical regulations. 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.

 

Main Responsibilities:

  • Ensure DHF content completion, integrity, and regulatory & standards compliance; collaboratively communicating & resolving gaps in support of MDR.
  • Execute and support on-time completion of Design Control Deliverables to support MDR.
  • Support 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 & execution of hardware and/or systems containing software, including active cross-functional root-cause analysis investigation & resolution activities.
  • Lead or support Risk Management activities from product Concept through Commercialization.
  • Support design test and inspection method development, and lead method validation activities.
  • Support manufacturing process development & qualification for new product commercialization and product changes.
  • Support internal & external audit responses.
  • Support product re-certifications.
  • Support the establishment of objective, measurable, discrete, and verifiable customer and product requirements.
  • Support objective component specification definitions, supplied component sampling plan development, and vendor qualifications.
  • Support execution of biocompatibility and sterilization qualifications.
  • Complete Document Change Request Reviews in a timely and objective manner.
  • Additional duties may be identified by functional management based on the current project/business objectives.
  • Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
  • 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.

 

Experience / Background:

  • Experience working in a broader enterprise/cross-division medical device business unit model preferred.  Defense or other regulated businesses may be acceptable.
  • 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.
  • 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: March 10, 2021, 1:15 pm
Category : Electrical Engineer
Job Type : Contract
Id : 8207
Region : Twin Cities

Looking for an Electrical Engineer to contribute to the development of innovative medical devices. This is a unique position for a motivated individual to have an impact on the entire system design from the development of individual circuits to the evaluation of the overall system performance. It is also a unique opportunity for someone who has wanted to get into the medical device industry to come join a high performing team without necessarily having medical device experience in the past.

 

Job Responsibilities and Duties: 

  • Develop, debug, modify, and test analog and digital circuits
  • Develop and utilize test protocols and systems to evaluate electrical component and product performance through bench testing and formal verification
  • Document hardware development through requirements, specifications, design descriptions, verification test methods, and test reports
  • Assist with formal verification of product to electrical safety and EMC standards
  • Create and manage component libraries within Altium circuit board development software
  • Learn new skills as needed to develop innovative medical equipment in a fast-paced environment

 

Minimum Qualifications:

  • 2+ years with BS degree in Electrical Engineering or related field
  • Experienced with analog and digital circuit design, evaluation, and debug techniques
  • Proficiency with at least one circuit board design software
  • Experienced with electrical test equipment
  • Strong verbal and written communication skills

 

Preferred Qualifications:

  • Experience with Altium circuit board design software
  • Experience with FPGAs
  • Prior experience working with software engineers to debug hardware interfaces to control software
  • Experience developing electrical hardware for medical devices


Posted: March 4, 2021, 11:22 am
Category : Technical Writer
Job Type : Contract
Id : 8198
Region : Twin Cities

The Global Transportation Process 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: 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: March 1, 2021, 12:15 pm
Category : Reliability Engineer
Job Type : Contract
Id : 8197
Region : Twin Cities

Seeking a Software Reliability Engineer who 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: March 1, 2021, 6:58 am
Category : Material Manager
Job Type : Contract
Id : 8196
Region : Twin Cities

The Sr. 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.

 

The ideal candidate is well versed in materials analysis, both polymers and metals (Chemical Engineer, Chemistry, Materials Science degrees or experience). The primary responsibility will be to support an alternative sterilization assessment where materials samples are being exposed to various sterilization chemistries. Metals, polymers, adhesive joints, welds, and products are being analyzed for evidence of any degradation reactions that were initiated by the new sterilization chemistry. Analytical techniques include, microscopy (optical and SEM), size exclusion chromatography, liquid chromatography mass spectrometry, electron spin resonance. Previous experience is desired but not a requirement. Looking for a highly motivated candidate willing to learn.

 

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: March 1, 2021, 6:50 am
Category : Reliability Engineer
Job Type : Contract
Id : 8192
Region : Twin Cities

Looking for a dynamic and adaptive Safety and Reliability Engineer with the desire to be part of proving and improving Cardiac Rhythm Management (CRM) implantable medical products and supporting instruments, helping to ensure they exceed the safety and reliability requirements and expectations of patients, clinicians, regulators, and the business.

As an integral member of project teams, working in collaboration with functional and cross-functional partners, you will be responsible for planning and leading product safety and reliability technical assessments and compliance activities to ensure that reliability and safety is proactively designed into products, that potential risks are analyzed and controlled, and that product/system performance is quantifiably predicted. Your work will span the product development lifecycle from research & technology, through development and early market release of new and derivative products.

 

A Day in the Life:

  • Contribute to the successful completion of major projects/programs
  • Provide imaginative, thorough and practical technical solutions to a wide range of problems, consistent with organizational objectives
  • Participate on cross-functional initiatives and teams, advocating for Quality
  • Develop and implement technical analyses, methods, and procedures, to drive product safety, reliability, and quality
  • Complete risk analysis of new design and processes, specifically planning, leading, executing, and integrating Risk Management activities to demonstrate product safety
  • Plan, lead, execute, and integrate Design for Reliability (DfR) activities, including coordinating and conducting technical reliability studies, to quantify product reliability
  • Plan, lead, execute, and integrate test and assessment activities, to demonstrate product performance and compliance
  • Recommend and apply statistical methods for analyzing data
  • Ensure that corrective measures meet reliability requirements and participate in preparing clinical evidence to demonstrate sufficient benefits to justify product risks
  • Concisely articulate risk management and reliability activities and conclusions in regulatory submissions and audits
  • Seek and propose ways to improve design reliability and process capability based on company metrics
  • Gain and apply thorough knowledge in US and foreign governmental regulations, agency guidelines, requirements, specifications, internal/corporate policies and required quality and reliability practices in assigned area
  • Ensure adherence to the business Quality Management System through procedure compliance and internal audits
  • Perform engineering reviews of quality records for compliance with stated requirements and impact on safety and reliability

 

Must Have: Minimum Requirements:

  • Bachelor's Degree in Engineering, Science or technical field with 2+ years of work experience in Engineering and/or Quality OR Advanced Degree in Engineering, Science or technical field with 0+ years of work experience in Engineering and/or Quality.

 

Nice to Have:

  • Ability to convert to full-time employee upon contract completion
  • Experience working on multi-disciplinary teams
  • Proficient in word processing, spreadsheets, and managing electronic data files
  • Advanced degree in Engineering or Science
  • Degree in Reliability Engineering, Biomedical Engineering, or Physics
  • Experience in Safety Engineering, Reliability/Quality Engineering, Systems Engineering, Product Development Engineering, Clinical, or Field Support
  • Proven understanding of reliability engineering principles
  • Ability to comprehensively apply degree-specific engineering principles in the design of highly reliable, complex systems
  • Strong understanding of and experience in the application of statistics, including experience with Minitab
  • Experience in a highly-regulated industry, preferably implantable medical devices
  • Understanding of implanted medical systems, products, therapies, and their use in the clinical environment, including customer expectations, common medical practice, and systems troubleshooting
  • Knowledge of cardiac anatomy, physiology, and primary disease states
  • Experience with 21 CFR Part 820 (Quality System Regulation), ISO 13485, etc.
  • Experience interpreting and applying industry standards (EN 45502/ISO 14708, IEC 60601, etc.) Experience in the application of Risk Management (ISO 14971) and hazard analysis and risk analysis techniques (e.g., PHA, HA, FTA, DFMEA)
  • Ability to independently lead investigations to identify system/product failures, hazards, hazardous situations, and harms
  • IBHRE Certified EP Specialist (Allied Professional) and/or CRE Certified
  • Exposure to or experience working in or with Design, Quality, Regulatory, Clinical and/or Manufacturing
  • Knowledge of Design for Reliability (DfR), Design for Reliability and Manufacturability (DRM), Design for Six Sigma (DFSS), Design for Lean Sigma (DFLS), and/or robust design practices


Posted: February 25, 2021, 7:01 am
Category : Technical Writer
Job Type : Contract
Id : 8190
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. This position 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: February 24, 2021, 6:15 am
Category : Quality Engineer - Medical Device
Job Type : Contract
Id : 8184
Region : Twin Cities

Seeking a Quality Engineer to primarily serve as a Risk Management Specialist working toward compliance with ISO 14971 - Application of Risk Management toward Medical devices. Intimate familiarity with ISO 14971 and experience in performing all aspect of Risk Management is highly preferred. Risk Management activities include but not limited to risk assessment, analysis, and evaluation, and driving risk reduction efforts within new product introduction teams.

A DAY IN THE LIFE:

  • Coordination and guidance to cross functional teams to define product requirements driven by system safety and performance objectives, develop strategy for achieving the defined objectives, and ensuring the objectives are met
  • Apply systems thinking in planning and executing design for reliability and design assurance methodologies and risk management for products or systems.
  • Performs and facilitates risk management, risk analysis, fault tree analysis, failure trending and failure analysis. Completes risk assessments, including Hazard Analysis (HAs), to evaluate impact of potential issues to patient safety and product performance
  • Provide input to design/process development, design controls, test method development, and design validation for achieving required levels of product safety and performance.
  • Conduct evaluation of new product development activities including requirements, design, development, documentation, integration, test, verification and validation.
  • Serve as a Design Quality Assurance reviewer/approver on design control documents, specifically those associated with product testing and characterization
  • Represent the organization as technical contact for reliability, design assurance, and/or safety and other technical projects and/or programs; create documentation in compliance with applicable procedures to meet project deliverables.

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: February 18, 2021, 7:13 am
Category : Quality Engineer - Medical Device
Job Type : Contract
Id : 8180
Region : Twin Cities

Seeking a Sr. Design Quality Engineer to provide quality engineering support in the design and development of innovative products through design controls planning, test method development, verification and validation. The individual shall support cross-functional development project teams and collaborate with other company and external engineering groups to ensure that new products and product changes are adequately evaluated/tested with respect to requirements and product Design History File is complete.

 

Responsibilities Include:

  • Evaluates product design and identifies potential design quality issues and drive technical decisions
  • Works within a development team to identify and implement effective controls to support the development, qualification, and commercialization of products to meet or exceed internal and external requirements.
  • Assists on-time completion of Design Control Deliverables
  • Accountable for ensuring Design Verification and Validation execution and deliverables comply with quality system regulations and internal requirements
  • Prepares risk management files and report for product releases, and has responsibility for active participation in risk management activities from product conception through commercialization
  • Supports design test and inspection method development and validation
  • Acts as an effective leader or team member in supporting quality disciplines, decisions, and practices.
  • Ensures DHF and DMR content completion, integrity, and regulatory & standards compliance; collaboratively communicating & resolving gaps
  • Supports and ensures the establishment of objective, measurable, discrete, and verifiable customer and product requirements
  • Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
  • Assure in the development and execution of streamlined business systems which effectively identify and resolve quality issues.
  • Supports in the development and maintenance of Quality Management System procedures
  • Support audits, CAPA/NCR/SCAR investigations and reports
  • Perform other related duties as assigned

 

Must Have: Minimum Qualifications

  • 4-6 years of experience with a Bachelor's Degree in engineering discipline; or
  • 2-4 years of experience with a Master's Degree in an engineering discipline; or
  • Medical or Pharmaceutical industry experience

 

Nice to Have

  • Experience designing and testing medical device preferred
  • Knowledge of GMP, ISO, QSR and other applicable international regulations, standards, Directives and Guidance
  • Good statistical data analysis skills
  • Design for Six Sigma and Critical to Quality training and experience a plus
  • Ability to manage multiple projects across multiple geographies.
  • Excellent verbal and written skills
  • Able to work independently, as well as in a team environment
  • Experience with 21CFR820, ISO13485, and ISO14971
  • Customer focused and service oriented
  • Ability to educate stakeholders, customers and management
  • Ability to interface with internal customers, suppliers and regulatory agencies
  • Experienced working with cross-functional and international teams
  • Knowledge of FDA and TUV requirements.
  • ASQ certification a plus


Posted: February 16, 2021, 6:45 am
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 : Software Engineer
Job Type : Contract
Id : 8174
Region : Twin Cities

The Software Engineer designs, develops, tests, debugs and implements operating systems components, software tools and utilities for a major medical device company. This position 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: 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 contact. 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 a University Degree and minimum of 2 years of relevant experience, or advanced degree with 0 years of experience.


Posted: February 15, 2021, 8:07 am
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/Regulatory
Job Type : Contract
Id : 8168
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 a Certified Supplier Program in receiving inspection to ensure cost effectiveness for a major medical device company. This position 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: 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: February 9, 2021, 11:00 am
Category : Mechanical Engineer
Job Type : Permanent
Id : 8137
Region : Twin Cities

The Mechanical Design Engineer is responsible for development of the precision alignment equipment that produces sensors. This includes concept design, detail design, testing, documenting, and transferring the design into production.

Core Responsibilities:

  • Mechanical design of precision alignment equipment
  • Design of custom machined and sheet metal parts
  • Design opto-mechanical mounts to provide precise alignment, adjustment, and robustness to meet critical optical performance requirements
  • Selection and integration of precision motion
  • Design for operator ease of use, human factors, and safety
  • Communicate with internal customers to define requirements
  • Collaborate with production on design manufacturability
  • Consult with manufacturing partners on part fabrication
  • Assemble and test final hardware
  • Create product drawings and project documents
  • Transition new designs to production and support existing production

Experience, Education and Competencies Required:

  • 3+ years of experience designing precision processing equipment, inspection equipment, precision equipment, sensors, or electro-mechanical instruments
  • Experience as a mechanical design engineer, designing custom machined and fabricated parts
  • B.S. degree in Mechanical Engineering, or equivalent field
  • Proficient in mechanical CAD (Pro/Engineer preferred) and exposure to CAD data management
  • Experience/knowledge of manufacturing processes especially machining and low volume sheet metal.
  • Experience in a structured development process from requirements definition, to concept design, to detail design, to testing, and implementation into production
  • Experience in, or ability to learn, operating a mill and lathe for part modification and fabrication
  • Must work well in teams with other Engineering disciplines, including Electrical, Optical, Software, and Manufacturing
  • Good interpersonal skills. Good oral and written communications.

Experience, Education and Competencies Preferred:

  • Mechanical design of precision sensors
  • Design of opto-mechanical assemblies a plus


Posted: January 20, 2021, 7:23 am
Category : Firmware Engineer
Job Type : Permanent
Id : 8134
Region : Wisconsin

Looking for a talented Lead Electrical Firmware Engineer to develop and maintain hardware and firmware for embedded systems. The ideal candidate will have experience in developing hardware and firmware for new products as well as being able to maintain products that have already been released. The candidate should also have experience with digital circuit design. This candidate will be spending 85% of their time writing embedded firmware (C code) and approximately 15% of their time developing and maintaining hardware.

Responsibilities:

  • Design, develop and maintain firmware for 8/16/32 bit microcontroller-based products
  • Troubleshoot and debug issues with firmware.
  • Write and maintain software in Visual Studio
  • Verify hardware works as designed
  • Document features, issues, and operation of firmware
  • Transfer knowledge to others within the company

Required Skills:

  • Minimum of 5 years work experience
  • C, C#
  • IP Networks
  • Digital circuit design
  • Ability to collaborate and communicate with a team
  • Willingness to learn new skills and programming languages

Desired Skills:

  • VB.NET
  • Microchip PIC Microcontrollers
  • Assembly language
  • Linux
  • Bluetooth
  • SIP
  • Analog circuit design
  • PCB topology
  • git
  • Jira/Confluence


Posted: January 19, 2021, 8:10 am
Category : Quality Engineer - Medical Device
Job Type : Contract
Id : 8127
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.

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: January 14, 2021, 6:36 am
Category : Mechanical Designer
Job Type : Contract
Id : 8099
Region : Twin Cities

Seeking a Mechanical Design Engineer to work within the Released Product Engineering design team. Responsible for leading mechanical design engineering projects for stimulator leads, neurostimulators and accessories.

Position Responsibilities

  • Mechanical Design Engineer for Neuromodulation Implantable Neuro Systems. These systems are used to treat movement, gastro-uro and pain disorders.
  • Lead and support design changes that are primarily mechanical in nature with the engineer cognizant of non-mechanical materials and electrical interfaces.
  • Balance deliverables on multiple simultaneous project assignments with minimal oversight.
  • Drive projects to closure within specified milestones while being flexible on project assignments.
  • Evaluate existing fielded products and lead design changes that improve manufacturability, quality, reliability, and/or reduce cost.
  • Demonstrate effective cross functional teaming by working with Manufacturing, Supply Chain, Quality, Reliability, and Regulatory Functions to qualify and implement design changes.
  • Responsible to lead and perform detailed design analysis on critical design elements, participate, support or potentially lead corrective action teams to resolve quality issues (per PIE, FI, NC and CAPA processes). Ensure compliance to quality management system for assigned tasks.
  • Effectively lead project elements in a cross functional teaming environment.

Basic Qualifications

  • B.S. in Mechanical Engineering or other related technical/engineering discipline with 2+ years of job-related experience; or MS degree with 0 years of job-related experience in the medical device industry.
  • Direct knowledge and experience working with Company subsystems related to DBS, SCS and/or PH therapies.
  • Experience working with Company Configuration Control Boards, Functional Review Boards and Day to Day (D2D) processes.
  • Demonstrated excellent written, verbal, and presentation/communication skills.
  • Proven ability to work independently with minimal oversight and complete tasks within scheduled milestones.

Desired/Preferred Qualifications:

  • Demonstrated excellent project management skills and high level of computer competency.
  • Knowledge and experience working with DRM/DFSS/Six Sigma Green Belt or Black Belt is a plus
  • Experience using engineering statistical tools/methods such as Minitab, Design of Experiments (DOE) methodologies, Hypothesis testing, capability analysis, measurement systems analysis and other six sigma methods as appropriate


Posted: December 10, 2020, 7:07 am
Category : Systems Engineer
Job Type : Contract
Id : 8040
Region : Twin Cities

The 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. This Engineer ensures the logical and systematic conversion of product requirements into total systems solutions that acknowledge technical, schedule, and cost constraints. Also, 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: 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 27, 2020, 9:48 am
Category : Software Engineering
Job Type : Permanent
Id : 8033
Region : Twin Cities

We are looking for a Senior Embedded Software Engineer to join our software team. A Senior Embedded Software Engineer is responsible for the architecture and implementation of embedded software for sensors. A Senior Software Engineer generally works at the direction of a Software Architect or Systems Engineer.

Core Responsibilities:

  • Design and implement embedded software for various sensor projects including new product development.
  • Design and implement unit tests and stress tests for validation of embedded software.
  • Document firmware architecture and communications interfaces.
  • Work closely with Electrical Engineering to debug and troubleshoot PCBA’s during board bring up, utilizing electronics troubleshooting tools such as logic and protocol analyzers and oscilloscopes.
  • Work closely with Software Engineering as they develop PC applications to control the sensors.
  • Provide support for legacy sensors, including designing and implementing solutions to challenges found in the field.

Experience, Education and Competencies Required:

  • BS Degree in Computer Science or Electrical Engineering (or similar).
  • 5+ years developing applications on custom electronic hardware.
  • Proficiency in C and C++ programming on embedded systems.
  • Strong electrical background and proficiency in reading electronic schematics, component datasheets.
  • Working with multi-discipline engineering teams throughout all phases of development.

Preferred Experience:

  • Embedded Linux development using Yocto and Bitbake, including driver development, integrating patches, Bitbake layer and recipe generation, and U-Boot.
  • Real time (super loop) firmware for micro-processors using SPI, I2C, UART, and SDIO to communicate with peripheral sensor IC’s.
  • Wireless communication protocols Bluetooth classic and WiFi (TCP/IP).
  • Wired communication over USB and Ethernet.
  • Image processing and other digital signal processing in an embedded environment.
  • Git and Microsoft TFS version control.


Posted: October 19, 2020, 1:58 pm
Category : BioMedical Engineer
Job Type : Contract
Id : 8011
Region : Twin Cities

The Biomedical Engineer designs, develops and provides safety testing, repair, and maintenance of biomedical equipment. Ensures that the biomedical equipment is in compliance with applicable regulatory requirements and quality control standards. Design studies and conduct research on enzyme reactions and the effects of organic compounds on biological processes. Participate in activities such as compound screening and compound optimization programs, and developing and running enzyme assays.

  • 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 6, 2020, 6:15 am
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 : Project Manager
Job Type : Contract
Id : 7715
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: August 7, 2020, 11:25 am
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 : Systems Engineer
Job Type : Contract
Id : 7922
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. This engineer ensures the logical and systematic conversion of product requirements into total systems solutions that acknowledge technical, schedule, and cost constraints. Also, performs functional analysis, timeline analysis, detail trade studies, requirements allocation and interface definition studies to translate customer requirements into hardware and software specifications.

POSITION RESPONSIBILITIES:

  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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: June 15, 2020, 12:29 pm
Category : Technicians
Job Type : Contract-to-Hire
Id : 7776
Region : Twin Cities

Seeking a Production Technician to support Semiconductor sensor products.  The Production Technician will support engineering with moderately complex engineering duties and/or hands-on tasks. Involved with the overall production and manufacturing of optical sensors or Semiconductor. Coordinate with hardware and software manufacturing engineering teams. Assist in the develop performance models and test procedures.

 

Key Responsibilities and Essential Functions:

  • Build, align, and calibrate sensor using hand tools, light meters, multimeters, alignment telescopes, autocollimators, theodolites, and lasers.
  • Support Design Engineers with testing and troubleshooting. Analyze test results and adjust equipment to bring it within specifications. Set up and conduct precision optical and mechanical measurements.
  • Coordinate with other departments to install, align, troubleshoot, calibrate, and document changes.
  • Participate in daily production communication meeting to resolve manufacturing issues such as process, fixtures, capacity, and materials to achieve the production build plan.
  • When required, candidate can be assigned to support production capacity to meet revenue plans.
  • Proficient with computer programs like MS Outlook, MS Word, MS PowerPoint, and MS Excel to communicate, calculate, and document.
  • Ability to read mechanical drawings, production build processes, and test procedures.
  • Work closely with APA (Advanced Prototyping Assembler) & Manufacturing Engineering team.
  • Required work hours is from 6:00am to 2:30pm with flexible hours to work outside of standard hours.
  • Other duties as assigned.

 

Experience, Education, and Competencies Required:

  • Two year technical degree in manufacturing or related field with two years of hands-on experience.
  • Ability to understand drawings, specifications, procedures, and geometric tolerances.
  • Self-driven with the ability to multi-task and prioritize within their assigned work scope.
  • Strong troubleshooting skills to decipher between sensor design, fixture, or software issue.
  • Able to articulate problem statement and provide technical strategy to problem solving.
  • Ability to work with minimal supervision, but does not supervise others.  Individual will not give work direction.  Will provide input to create a solution for process change considerations to be approved by the Manufacturing Engineer or Production Supervisor.
  • Experience, Education, and Competencies Preferred:
  • Five years of optics or semiconductor hands-on experience.
  • Optical component handling, cleaning, and bonding experience preferred.
  • Experience with optomechanical / electromechanical assembly operations preferred.
  • Working knowledge of small to medium electro/mechanical assembly experience.


Posted: November 4, 2019, 11:51 am
Category : Project Manager
Job Type : Permanent
Id : 7765
Region : Twin Cities

Seeking a Project Manager to be the primary customer interface during all project phases of design, supply, production, factory testing, delivery, install, and customer site acceptance testing. This individual will be responsible for project leadership on build to print and custom automation design and build projects.

Responsibilities:

  • Provide leadership to drive project related decisions (technical & non-technical)
  • Develop detailed project plans and specification documents
  • Identify resources by discipline required for successful project milestone deliveries.
  • Work with organization management on early identification and labor durations of project resources
  • Plan and lead all internal and customer project design reviews throughout project execution
  • Execute project plans which are designed to exceed financial targets
  • Manage quality, schedule, cost, and customer satisfaction
  • Manage contract compliance as it relates to "as sold" scope, allowable deviations, scope changes requiring purchase order adders, timely release of invoicing, and payment receivables

Requirements:

  • Ideal candidate will have the ability to manage multiple projects of varying degrees of complexity simultaneously, proven leadership, planning and organizational skills, and strong technical background in automation design.
  • Candidate must demonstrate proven "systems" approach to project management and the drive to consistently deliver on commitments.
  • Qualified candidate will have a BS or MS in Engineering or Technical discipline and 8-10 years of relevant experience. Significant team leadership experience, preferably in a project environment, is desired.



Posted: October 11, 2019, 11:09 am
Category : Controls Engineer
Job Type : Contract
Id : 7725
Region : Twin Cities

Seeking a Controls Engineer to develop control system design and application of various technologies including: multi-axis motion control, image processing, vision-guided robotics, industrial instrumentation & automatic control. This position will provide technical leadership in a team-oriented work environment, interface with customers on technical projects, system programming PLC/motion/vision, startup/commissioning of machine control systems.

Position Requirements:

  • BS or MS in Mechanical or Electrical Engineering with control system emphasis (min 3.2 GPA) and relevant intern or co-op experience.
  • Strong electromechanical aptitude.
  • Motion control/Robotics experience (Delta Tau, Adept, Yamaha, Epson).
  • PLC/PC programming experience (Allen-Bradley, GE Fanuc, etc.).
  • Vision experience (Cognex, DVT, Adept).
  • Solid organizational skills.
  • Strong desire to work in a fast-paced, entrepreneurial environment.
  • Ability to consistently deliver on commitments.


Posted: August 28, 2019, 12:46 pm
Category : Controls Engineer
Job Type : Permanent
Id : 7556
Region : Twin Cities

Seeking a Systems Engineer to develop control system design and application of various technologies including: multi-axis motion control, image processing, vision-guided robotics, industrial instrumentation & automatic control. This position will provide technical leadership in a team-oriented work environment, interface with customers on technical projects, system programming PLC/motion/vision, startup/commissioning of machine control systems.

Requirements

  • BS or MS in Mechanical or Electrical Engineering with control system emphasis (min 3.2 GPA) and relevant intern or co-op experience.
  • Strong electromechanical aptitude.
  • Motion control/Robotics experience (Delta Tau, Adept, Yamaha, Epson).
  • PLC/PC programming experience (Allen-Bradley, GE Fanuc, etc.).
  • Vision experience (Cognex, DVT, Adept).
  • Solid organizational skills.
  • Strong desire to work in a fast-paced, entrepreneurial environment.
  • Ability to consistently deliver on commitments.


Posted: December 6, 2018, 9:22 am
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