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Development Resource Group

Get updates on all the job openings from Development Resource Group.

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 : Electrical Engineer
Job Type : Contract
Id : 7964
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: July 31, 2020, 1:42 pm
Category : Test Engr - Technical
Job Type : Contract
Id : 7962
Region : Twin Cities

The Test Engineer in the Radio Quality function has primary responsibility for the planning and executing of wireless and telecommunications compliance testing to enable world-wide radio frequency approvals for company products. Under the general direction of the Radio Quality Manager, the Test Engineer in the Radio Quality group is responsible for working cross-functionally to understand device and instrument functionality, configure test samples, understand wireless and telecommunication requirements, and execute compliance testing, as well as planning and coordination of radio and telecommunication activities. In addition, the Test Engineer may review or develop compliance documentation, engineer test set-ups, and create procedures to support internal requirements.

Qualifications:

  • Basic knowledge of RF instrumentation and other electronic lab equipment such as spectrum analyzers, signal and waveform generators, oscilloscopes, power meters and sensors, and RF amplifiers.
  • Understanding of active implantable medical device functions and device programming at a system and firmware level.
  • Skills to interpret and understand regulatory requirements and standards.
  • Experience with test equipment, set-ups and test methods used to assess wireless and telecommunications compliance.
  • Operation of medical device programmers and associated instruments.
  • Knowledge and basic understanding of 50 ohm measurement systems, shielding and filtering.

Preferred Qualifications:

  • Familiar with radio and EMC regulations and standards such as US FCC, Canada ISED, European ETSI and Directives.
  • Experience in evaluating products which contain wireless and telecommunication systems.
  • Knowledge of wireless communication systems used in active implantable medical devices and instruments.
  • Working knowledge of LabVIEW and MATLAB.
  • Knowledge and basic understanding of electromagnetic interference (EMI) and electromagnetic compatibility (EMC).

Education:

  • 4 year degree in an electronics-related field such as Engineering Technology, Electrical Engineering, Systems Engineering, Computer Engineering or similar discipline.

Experience:

  • 3-5 years of experience with a desire to perform hands-on activities and interface with product development teams.


Posted: July 29, 2020, 12:28 pm
Category : Reliability Engineer
Job Type : Contract
Id : 7961
Region : Twin Cities

The Principal Reliability Engineer develops, coordinates and conducts technical reliability studies and evaluations of engineering design concepts and design of experiments (DOE) constructs for a major medical device company. A candidate must have Medical Device Reliability experience to be considered for this position.

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



Posted: July 29, 2020, 10:37 am
Category : Reliability Engineer
Job Type : Contract
Id : 7960
Region : Twin Cities

As a Reliability Engineer, you will have responsibility to ensure consistent, timely, and accurate risk evaluations of Medical Device therapies, diagnostics, devices, and systems throughout the lifecycle of the product. You are also expected to monitor and understand the performance of company products. This position may also include reliability engineering responsibilities such as ensuring products are developed and manufactured with highest product quality and meet all applicable product quality, design and manufacturing process requirements. Also, this role may support CAPA and design/process changes for released product.

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

  • Prepare Post Market Surveillance Reports for assigned product areas.
  • Prepare risk management/product safety deliverables using knowledge of risk management standards and procedures.
  • Compiles and analyzes product performance reports.
  • Ensures that corrective measures meet acceptable reliability standards.
  • As necessary, proposes changes in design or testing to improve system and/or process reliability.
  • Develops, coordinates and conducts technical reliability studies and evaluations of engineering design concepts and design of experiments (DOE) constructs.
  • Recommends design or test methods and statistical process control procedures for achieving required levels of product reliability.
  • Completes risk analysis studies of new design and processes.
  • Compiles and analyzes performance reports and process control statistics; investigates and analyzes relevant variables potentially affecting product and processes.
  • Ensures that corrective measures meet acceptable reliability standards.
  • Analyzes preliminary plans and develops reliability engineering programs to achieve company, customer and governmental agency reliability objectives.
  • May develop mathematical models to identify units, batches or processes posing excessive failure risks.
  • As necessary, proposes changes in design or formulation to improve system and/or process reliability. May determine units and/or batches requiring environmental testing, and specifies minimum number of samples to obtain statistically valid data.
  • Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering and overseeing the projects from design to implementation while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education (typically University).
  • Autonomy: Established and productive individual contributor. Works independently with general supervision on larger, moderately complex projects / assignments.
  • Organizational Impact: Sets objectives for own job area to meet the objectives of projects and assignments. Contributes to the completion of project milestones . May have some involvement in cross functional assignments.
  • Innovation and Complexity: Problems and issues faced are general, and may require understanding of broader set of issues or other job areas but typically are not complex . Makes adjustments or recommends enhancements in systems and processes to solve problems or improve effectiveness of job area.
  • Communication and Influence: Communicates primarily and frequently with internal contacts. External interactions are less complex or problem solving in nature. Contacts others to share information, status, needs and issues in order to inform, gain input, and support decision making.
  • Leadership and Talent Management: May provide guidance and assistance to entry level professionals and / or employee in Support Career Stream.
  • Required Knowledge and Experience: Requires practical knowledge and demonstrated competence within job area typically obtained through advanced education combined with experience. Requires a University Degree and minimum of 2 years of relevant experience, or advanced degree with 0 years of experience.


Posted: July 29, 2020, 10:05 am
Category : Quality/Regulatory
Job Type : Contract
Id : 7959
Region : Twin Cities

The Risk Management 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 risk 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 completion of Risk Management Deliverables
  • Maintain Risk Management deliverables to ensure continued acceptability of product based on post market feedback
  • Support on-time execution of Quality Plans for internal development, OEM-based, Clinical Product Development (CPDP), and design change projects
  • Support Risk Management / Cybersecurity activities from product Concept through product obsolescence, including post-market activities and support for submissions.
  • 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
  • 3 - 6 years' experience
  • Previous engineering experience preferred
  • 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: July 29, 2020, 9:57 am
Category : Mechanical Designer
Job Type : Contract
Id : 7957
Region : Twin Cities

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

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


Posted: July 27, 2020, 9:20 am
Category : Quality Engineer - Medical Device
Job Type : Contract
Id : 7956
Region : Twin Cities

Seeking a New Product Introduction (NPI) Quality Engineer to initiate medical device quality assurance activities. These activities must be in accordance with FDA Quality System Regulation, ISO13485 and other international standards. This position will 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.

POSITION REQUIREMENTS:

  • Bachelors Degree
  • 2-4 years of experience in Medical Device Company


Posted: July 27, 2020, 8:59 am
Category : Quality Engineer - Medical Device
Job Type : Contract
Id : 7955
Region : Twin Cities

Seeking a Senior Quality Engineer to conduct a gap analysis of the current state of process validation vs EUMDR validation requirements for a major medical device company. This will determine what activities will be required to remediate the validated state to meet EUMDR requirements. This position will also write/execute appropriate plans and protocols supporting remediation efforts. Also, provide routine updates to management team on progress of remediation activities.

Specific Skills:

  • Experience with Process Validation, including Inspection Method validation activities.
  • Basic knowledge of EUMDR GSPR requirements.
  • Excellent written and verbal communication skills
  • Basic knowledge of statistics using Minitab
  • Ability to work in a team environment with technicians and engineers.


Posted: July 27, 2020, 8:24 am
Category : Technical Writer
Job Type : Contract
Id : 7954
Region : Twin Cities

We are recruiting for a Technical Writer to join our team. In this hands-on role, you will be a critical contributor in the development of compelling software solutions for products within the Electrophysiology Division of a major medical device company. You will be responsible for decomposing use cases and system requirements in to clear and concise software requirements for software applications used in diagnostic cardiology devices.

Primary Responsibilities:

  • Write clear, concise, and testable software requirements in accordance with the company’s Quality System
  • Facilitate feedback on written requirements from software development, software systems, software test, and others, as necessary
  • Create tracing from higher level requirements to software requirements in DOORS
  • Maintain and update software requirements in DOOR
  • Generate reports and publish software requirements from DOORS

Required Qualifications:

  • Bachler’s Degree with 8+ years’ experience
  • Demonstrated knowledge and experience writing and managing software requirements
  • Demonstrated knowledge and experience working with DOOR
  • Previous experience working in a regulated industry such as automotive, aerospace, healthcare, or defense
  • Excellent verbal and written communication skills, with ability to communicate to all levels of the organization

Preferred Qualifications:

  • Familiarity with C++ and Python programming languages
  • Advanced DOORS tool experience including scripting and reporting
  • Knowledge of 62304 and other standards applicable to Class II and Class III medical devices
  • Familiarity of FDA Cybersecurity Guidance and GDPR


Posted: July 27, 2020, 7:43 am
Category : Quality Engineering
Job Type : Contract
Id : 7953
Region : Twin Cities

Seeking 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.
  • Must have experience with CAPA and Procedure work


Posted: July 27, 2020, 7:35 am
Category : Quality Engineering
Job Type : Contract
Id : 7951
Region : Twin Cities

Seeking a Design Assurance Engineer to work closely with Development/Manufacturing/Quality Engineering to ensure compliance with the company's  quality system. You will work closely with Regulatory Affairs personnel (internal or external) to monitor regulatory compliance. Monitor quality assurance efforts to ensure that the company's products conform to quality standards. Partner with Research/Development and Manufacturing Engineering during new product start-ups and establish checkpoints for testing new products and processes.

 

The Design Assurance Engineer is responsible for :

  • Following established GMP/ISO compliant quality system practices.
  • 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.
  • 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: July 24, 2020, 12:40 pm
Category : Software Test Engineer
Job Type : Contract
Id : 7950
Region : Twin Cities

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

Responsibilities include:

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

Experience and Education Required:

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


Posted: July 22, 2020, 2:16 pm
Category : Software Engineer
Job Type : Contract
Id : 7949
Region : Twin Cities

We are recruiting for a Software Engineer to join our team. In this technical role, 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. Under the guidance and direction of an experienced engineer, you will be responsible for developing use cases, reviewing software design, and decomposing higher level requirements in the development of software applications embedded in diagnostic cardiology devices. Additionally, you will participate in all phases of the software lifecycle, including concept development, requirements, design, implementation, and testing.

Primary Responsibilities:

  • Participate in software feature definition activities
  • Works with Software Development, Systems Engineering, Human Factors, Clinical Engineering, and other stakeholders to develop software use cases.
  • Generates clear and concise software requirements
  • Creates tracing from higher level requirements to software requirements
  • Reviews software designs to ensure they implement the appropriate software requirements
  • Assists in software integration activities to ensure software behaviors are appropriate
  • 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

Required Qualifications:

  • Bachler’s Degree in Engineering (Computer, Electrical, Computer Systems, Systems, or Software), Computer Science, or related discipline
  • 1-3 years of software engineering design and development or systems engineering experience
  • Knowledge of 62304 and other standards applicable to Class II and Class III medical devices
  • Demonstrated knowledge and experience working with C++
  • Experience with creating and managing requirements and translating them into effective architectures and software design
  • Previous experience working in a regulated industry such as automotive, aerospace, healthcare, or defense
  • 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
  • Well versed in draft FDA Cybersecurity Guidance and GDPR
  • Experience with complex electromechanical systems including hardware, embedded firmware, disposables, and software


Posted: July 22, 2020, 1:09 pm
Category : Quality Engineering
Job Type : Contract
Id : 7948
Region : Twin Cities

We are seeking a high caliber Development Quality Engineer I. This engineer assures 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. Each employee can make a difference and has the power, either individually or as a team, to influence the success of the company. We are team-oriented, fast-paced and progressive. We value people with great ideas who partner with others both internally and externally to take action and accomplish goals.

Responsibilities:

  • Execute on-time completion of design control deliverables
  • Design verification and validation test planning
  • Design verification and validation test protocols, execution and reports
  • Design input output trace matrix
  • Design History File organization
  • Customer, system, and product requirement review
  • Regulatory responses and submissions
  • Risk/hazard analysis and risk management plan/reports
  • Design specification reviews
  • Quality plans
  • Design change plan/reports
  • Investigate internal and external audit findings and write responses
  • Corrective and preventive action resolution
  • Complete document change requests
  • Ability to work independently with minimal/no supervision
  • Maintain high standards for content completion, integrity, and regulatory & standards compliance; collaboratively identifying, communicating & resolving gaps
  • 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
  • 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
  • Perform other duties and responsibilities as assigned by functional management based on the current project/business objectives including up to 10% travel and regular predictable attendance

Minimum Experience, Education & Knowledge:

  • 0-2 years’ experience in R&D or Quality role
  • Bachelor level degree in an Engineering Discipline or other Technical Field
  • Solid communication and interpersonal skills
  • Strong verbal communications and written communications with ability to effectively communicate at multiple levels in the Organization
  • Advanced computer skills, including and report writing skills
  • Ability to work within a team and as an individual contributor in a fast-paced, changing environment
  • Multitasks, prioritizes and meets deadlines in timely manner
  • Strong organizational and follow-up skills, as well as attention to detail

Preferred qualifications and education:

  • Degree in Mechanical, or Biomedical Engineering
  • Previous Quality engineering experience and demonstrated use of Quality tools/methodologies, statistical/data analysis
  • Prior medical device experience preferred
  • Working knowledge of FDA 21 CFR Part 820, GMP, and ISO 13485



Posted: July 22, 2020, 12:54 pm
Category : Mechanical Designer
Job Type : Contract
Id : 7947
Region : Twin Cities

Seeking a Mechanical Design Engineer for Design Characterization Testing Protocols & Reports, Design Verification Testing Protocols and Reports, Component/Assembly Design, Test Equipment Qualification, Test Method Validation, dFMEAs, may be responsible for the transfer from R&D to manufacturing for a major medical device company. Must have a bachelors degree and 2 years medical device experience.



Posted: July 21, 2020, 3:03 pm
Category : Reliability Engineer
Job Type : Contract
Id : 7945
Region : Twin Cities

The Principal Reliability Engineer develops, coordinates and conducts technical reliability studies and evaluations of engineering design concepts and design of experiments (DOE) constructs for a major medical device company. A candidate must have Medical Device Reliability experience to be considered for this position.

  • 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: 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 decisionmaking.
  • Leadership and Talent Management: Typically provides guidance, coaching and training to other employees within job area. Typically manages major / moderately complex projects, involving delegation of work and review of work products, at times acting as a team leader.
  • Required Knowledge and Experience: Requires mastery of a specialty area and full knowledge of industry practices, typically obtained through advanced education combined with experience. May have broad knowledge of project management. Requires a University Degree and minimum 7 years of relevant experience, or advanced degree with a minimum of 5 years of relevant experience.


Posted: July 17, 2020, 9:35 am
Category : R&D Engineer
Job Type : Contract
Id : 7944
Region : Twin Cities

Seeking a Senior R&D Engineer – EU MDR to work on cardiac occluders and associated delivery system - remediation and continuous improvement activities for a major medical device company.

POSITION RESPONSIBILITIES:

  • Perform, summarize and present research to assist the team in meeting project requirements
  • Participate in or lead problem-solving investigations
  • Develop or improve test methods utilizing skill sets including mechanical design, prototyping, problem solving and measurement systems analysis
  • Work with cross-functional teams to establish the device lifetime for each product
  • Support materials compliance teams with BOM, identification and verification of patient contacting and invasive component list
  • Updates to DHF, design inputs/outputs and product specification as applicable (from detailed gap assessment)
  • Update CAD files, design prints as necessary (materials compliance)
  • Support design quality engineers with risk management updates (frequency of occurrence and assessment of risks)
  • Ensure biocompatibility documentation is complete, update as necessary with shared biocompatibility services
  • Execute V&V work (to current standards as applicable)
  • Support inputs for General Safety and Performance Requirements (GSPR)

POSITION REQUIREMENTS:

  • 3-7 years’ experience
  • Familiar with design controls and implantable device
  • Continuous improvement / sustaining engineering experience
  • Previous work on U.S. class II or class III devices, class III preferred
  • Design assurance / development quality experience a plus
  • Experience working with nitinol a plus
  • Experience working with mechanical devices a plus
  • Working knowledge of the E.U. medical device regulation a plus


Posted: July 17, 2020, 8:00 am
Category : Systems Engineer
Job Type : Contract
Id : 7943
Region : Twin Cities

The Product Engineer is a specialty under the umbrella of a systems engineering discipline that focuses on the integration of package and labeling requirements within the larger therapy system for a major medical device company. The position will provide technical leadership for the Product Engineering Team, owning the packaging and labeling product architecture, requirement definition, requirements trace, verification/validation support, and manage associated Safety Risk Management interfaces.

Specific responsibilities include:

  • Work with peer systems engineer(s) during development of user needs & intended uses.
  • Ensure seamless and cohesive development and maintenance of product architecture and requirements to support the entire product lifecycle.
  • Develop and maintain the communication channels required to effectively and efficiently manage workflows between package design engineering, systems engineering, human factors engineering, risk management, and regulatory affairs.
  • Provide independent review of packaging and labeling design change control, and verification /validation rationale.
  • Contribute and build domain knowledge around implantable medical device-based systems, their clinical use and application.
  • Establish and advocate for best practices and continuous improvement as to mature Product Engineering and associated processes (Center of Excellence).
  • Champion consistent implementation of the Quality System across projects

QUALIFICATIONS

  • The candidate should be familiar with a range of systems engineering methods and tools, with demonstrated proficiency. In addition to strong systems engineering skills and experience, they must be comfortable dealing with ambiguity, and be confident in applying engineering experience to make or facilitate teams through pragmatic choices throughout product development.
  • The candidate must be a self-starter, have a strong work ethic, and have a track record of driving initiatives to achieve objectives. Experience as a creative problem solver, passion for continuous improvement, creativity, and having the ability to work autonomously and within a team setting are all required attributes.
  • In support of the above, the candidate must demonstrate excellent oral and written skills with the ability to interface with a variety of disciplines.

BASIC QUALIFICATIONS:

  • Education - Bachelor of Science Degree in Engineering
  • Experience - 4+ years of job-related experience with a bachelor’s degree; or 2+ years of job-related experience with a master’s degree.

DESIRED/PREFERRED QUALIFICATIONS:

  • Bachelor's or master’s degree in Systems Engineering, Packaging Engineering, Biomedical Engineering, Mechanical Engineering, Electrical Engineering.
  • Experience working in cross-functional team effort.
  • Proven ability to accomplish critical project level objectives in a team environment.
  • Knowledge of or experience working in a regulated and/or FDA medical device environment. Knowledge of or experience working with ISO and Quality System Regulation requirements.


Posted: July 16, 2020, 7:12 am
Category : Firmware Engineer
Job Type : Contract
Id : 7798
Region : Twin Cities

Seeking a Senior Embedded Software Engineer to design & develop reliable, maintainable, testable software for products used in a wide variety of applications based on 8/16/32/64-bit and multicore processors running no operating system to embedded RTOS, Linux, Windows, etc..

 

Responsibilities:

  • Participate in overall system design and analysis activities from new product concept and customer requirements to risk analysis to verification and validation.
  • Create, document and maintain software architectures.
  • Code, debug and test software on a wide variety of platforms and operating systems.
  • Write and maintain software specifications, plans and reports.
  • Follow documented software processes and contribute to continuous process improvement.
  • Work and communicate with leaders, engineers and project managers to ensure project completion.
  • Support project planning and project proposal efforts.
  • Present verbally in one-on-one or group settings.
  • Other duties as assigned.

 

Requirements:

  • Minimum Bachelor of Science in Electrical Engineering, Computer Science, Software Engineering or equivalent (Master's degree preferred).
  • Minimum 8+ years of experience in new product development.
  • Experience with the product development process ranging from requirements development, prototyping, verification and product release.
  • Must have significant experience developing software in C and/or C++ for embedded systems.
  • Experience with basic software and hardware debug tools (JTAG debuggers, oscilloscopes, etc.).
  • Experience working in teams with multiple engineering disciplines and external 3rd parties.
  • Strong verbal and written communication skills including the ability to write technical specifications and design documentation.
  • Ability to manage multiple priorities.
  • Ability to provide leadership and guidance to junior level staff.
  • Ability to work in a fast paced environment with quickly changing priorities.

 

Desired Experience:

  • Experience in medical device design or other regulated industries.
  • Working with implantable devices.
  • Leading software projects; i.e. project manager, project lead etc.
  • Managing project budget, schedule, progress towards milestones
  • Experience with software processes compliant with IEC 62304.
  • Writing and executing software unit, integration and verification tests.
  • Writing requirements from high level customer needs to detailed specifications.
  • Risk management activities compliant with IEC 14971.

 

 



Posted: July 15, 2020, 12:03 pm
Category : R&D Engineer
Job Type : Contract
Id : 7941
Region : Twin Cities

Seeking a talented R&D Engineer, Human Factors Engineer to apply human factors and ergonomics expertise to the definition, design, and evaluation of products within the R&D division of Electrophysiology Systems, this is part of the Atrial Fibrillation business unit.

Position Responsibilities:

  • Apply knowledge of human factors principles (human performance and limitations – perceptual, cognitive, motor skills, anthropomorphic) and techniques (knowledge acquisition, user-interface design, usability evaluation) to cardiac electrophysiology systems product development.
  • Organize and direct the work of staff and outside consultants working on human factors tasks to effectively and efficiently support product development efforts within the organization.
  • Deliverables include, but are not limited to: Usability engineering files, Task analyses, and Usability risk analyses
  • Usability testing throughout the product development process, from formative testing of early prototypes through usability validation of final designs.
  • Develop collaborative working relationships with other functions across the organization, including but not limited to the following: Work with regulatory affairs to develop strategies for new product submissions, create submission packages, and respond to questions from regulatory agencies
  • Work with design quality to ensure that the company’s usability engineering processes and methodologies meet and surpass the latest expectations of regulatory agencies and provide tangible value for our customers and our business.
  • Keep abreast of regulations and best practices for medical device human factors (e.g. IEC 62366, AAMI HE75, ISO 14971, and the latest FDA guidance on applying human factors engineering) and advice management regarding potential improvements to internal processes and regulatory issues related to human factors engineering.
  • Represent in meetings with regulatory agencies, at human factors professional meetings and conferences, and as a member of standards committees.

Position Requirements:

  • Proven ability to work with multidisciplinary teams that may include other human factors experts.
  • Proven ability to interface with customers in a highly professional manner.
  • Proven ability to apply user-centered design and human factors/usability engineering principles to product research, development and design.
  • Experience in medical device development.
  • Ability to quickly assimilate advanced domain knowledge.
  • Excellent verbal and written communication and presentation skills
  • Education: M.S. degree in Human Factors Engineering or Cognitive Psychology or M.S. degree in Biomedical Engineering with extensive human factors coursework.
  • Minimum of 5 years of relevant human factors/usability engineering experience in hardware-software systems product development; prefer 10+ years of experience


Posted: July 14, 2020, 11:42 am
Category : Systems Engineer
Job Type : Contract
Id : 7939
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: July 13, 2020, 6:15 am
Category : Quality/Regulatory
Job Type : Contract
Id : 7937
Region : Twin Cities

The Senior Product Engineer will be responsible for production support engineering with respect to testing methods, procedures, and problems; device specification and yield problems; minor redesign of devices and masks; analysis of customer returns; and optimizing device production relative to cost constraints for a major medical device company.

POSITION RESPONSIBILITIES:

  • Responsible for maintaining continuity of supply of components purchased from suppliers
  • Responsible for all supplier change activities
  • Responsible for supplier process improvement activities
  • Responsible for CAPAs associated with suppliers
  • Leads cross-functional teams to drive root cause and final resolution of supplier related issues
  • Leads cross-functional quality improvement and cost improvement projects
  • Apply engineering principles in order to improve suppliers’ processes

BASIC QUALIFICATIONS:

  • Bachelor of Science or Master of Science in Engineering
  • Bachelors’ degree with 4-7 years of experience or Masters’ degree with 2-5 years of experience

DESIRED/PREFERRED QUALIFICATIONS:

  • Process knowledge around processing of specific commodities like chemicals, polymers, metals
  • Proven problem solving skills; knowledge of DMAIC is preferred
  • Strong project management and leadership skills
  • Ability to multi-task and be organized
  • Strong interpersonal skills to work across multiple functions to resolve issues
  • Strong verbal and written communication skills
  • Demonstrated strong technical writing skills
  • Basic statistics, including Six Sigma principles
  • Minitab for statistical data analysis
  • DOEs, SPC, FMEA, Gage R&R knowledge
  • Experience working in regulated industry like medical devices


Posted: July 9, 2020, 9:36 am
Category : Quality/Regulatory
Job Type : Contract
Id : 7938
Region : Twin Cities

Seeking a Senior Component Engineer for the following responsibilities, other duties may be assigned:

  • Support Engineering team on PDP projects, product transfers, CM conversions, cost saving and material replacement projects.
  • Provide engineering support to supplier manufacturing operation.
  • Partner with suppliers to develop manufacturing control plans to ensure appropriate acceptance activities are in place prior to commercialization
  • Develop and maintain control strategies and inspection procedures for components/materials to ensure supplier parts meet specification requirements.
  • Lean and Six Sigma understanding; ability to time study, calculate Takt time, line level; Pareto rejects, filter key inputs to process to generate a DOE. Design and execute optimization DOEs
  • Utilize basic statistical methods to support engineering testing.
  • Perform statistical data analysis to determine feature-level capability and performance.
  • Ensure supplier measurement capabilities through robust measurement system analyses.
  • Apply first principles of physics and material behaviors in the development of component specifications and supplier processes.
  • Develop and execute characterization, qualification and reliability test plans and reports in partnership with selected suppliers.
  • Apply knowledge of supplier and internal manufacturing methods, procedures, inspection, and tests techniques.
  • Lead issue resolution of complex problems as they relate to supplied components and materials.
  • Leads cross-functional teams to drive root cause and final resolution of supplier related issues within contracted project schedules and budgets
  • Lead engineering projects intended to replace obsolete materials, validate process changes, or implement machinery upgrades/replacement.
  • Tasks including: Project management deliverables; protocol generation; report generation; supplier interactions; technical assessment of changes; and risk review
  • Process change orders or supplier change orders in configuration management software (i.e: AGILE).
  • Lead supplier audits and drive First Time Quality events to reduce risks
  • Use Design Reliability Manufacturability (DRM) methodology to improve product quality and reliability:
  • Understand production lines- asses’ risks, audit, how cell is aligned, lean maturity
  • Ability to work with cross-functional design teams. Be the voice of ops to explain implications of design changes on regulations and lines
  • Ability to understand design print creation and finalization, tolerances
  • Establish reliability & predictive capability of process and components
  • Requirements flow down and tracing design outputs to inputs
  • Deploy Lean and Six Sigma methodologies to ensure strong root cause investigations

BASIC QUALIFICATIONS:

  • Bachelor’s Degree in Mechanical, Chemical, or Biomedical Engineering or Physics
  • 5-7 years in a regulated industry; 2-5 years with a master’s degree

DESIRED/PREFERRED QUALIFICATIONS:

  • Manufacturing experience in regulated industry, preferably medical device industry
  • Development experience in regulated industry
  • Strong statistical background
  • Strong interpersonal and written communication skills
  • Demonstrated strong technical writing skills
  • Must be capable of coordinating across multiple functions, locations, and cultures to resolve issues
  • Project management experience
  • Six Sigma knowledge – DRM Green Belt Preferred
  • Demonstrated success in process improvement and control
  • Understanding of material properties and how they can be impacted by supplier processes.
  • Excellent written and oral communication skills
  • Knowledge of measurement systems and Suppliers capabilities
  • Technical writing experience
  • MS Office experience
  • Project management experience
  • DOEs, SPC, FMEA, GMP experience


Posted: July 9, 2020, 9:30 am
Category : Reliability Engineer
Job Type : Contract
Id : 7936
Region : Twin Cities

The Senior Reliability Engineer develops, coordinates and conducts technical reliability studies and evaluations of engineering design concepts and design of experiments (DOE) constructs for a major medical device company.

  • Recommends design or test methods and statistical process control procedures for achieving required levels of product reliability.
  • Completes risk analysis studies of new design and processes.
  • Compiles and analyzes performance reports and process control statistics; investigates and analyzes relevant variables potentially affecting product and processes.
  • Ensures that corrective measures meet acceptable reliability standards.
  • Analyzes preliminary plans and develops reliability engineering programs to achieve company, customer and governmental agency reliability objectives.
  • May develop mathematical models to identify units, batches or processes posing excessive failure risks.
  • As necessary, proposes changes in design or formulation to improve system and/or process reliability.
  • May determine units and/or batches requiring environmental testing, and specifies minimum number of samples to obtain statistically valid data.
  • Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering and overseeing the projects from design to implementation while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education (typically University).
  • Autonomy: Seasoned individual contributor. Works independently under limited supervision to determine and develop approach to solutions. Coaches and reviews the work of lower level specialists; may manage projects / processes.
  • Organizational Impact: May be responsible for entire projects or processes within job area. Contributes to the completion of work group objectives, through building relationships and consensus to reach agreements on assignments.
  • Innovation and Complexity: Problems and issues faced are difficult, and may require understanding of multiple issues, job areas or specialties . Makes improvements of processes, systems or products to enhance performance of the job area. Analysis provided is indepth 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 decisionmaking.
  • Leadership and Talent Management: May provide guidance, coaching and training to other employees within job area. May manage projects, requiring delegation of work and review of others' work product.
  • Required Knowledge and Experience: Requires advanced knowledge of job area combining breadth and depth, typically obtained through advanced education combined with experience. May have practical knowledge of project management. Requires a University Degree and minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience.



Posted: July 9, 2020, 9:00 am
Category : R&D Engineer
Job Type : Contract
Id : 7934
Region : Twin Cities

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

Position 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.

Position 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: July 7, 2020, 1:10 pm
Category : Firmware Engineer
Job Type : Contract
Id : 7933
Region : Twin Cities

Looking for a Senior Firmware Engineer to join an R&D team to design and develop new and modifications to firmware for the cardiac ablation systems for a major medical device company.

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

  • 8+ years of embedded software design and development with Bachelors Degree in Engineering (Electrical or Software)
  • 6+ years of experience with Masters Degree or
  • 5+ years of experience with PhD
  • Embedded software development in C language
  • Strong experience working with hardware, including ability to read schematics, data sheets and interface specifications
  • 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: July 6, 2020, 2:18 pm
Category : R&D Engineer
Job Type : Contract
Id : 7932
Region : Twin Cities

Seeking an Associate Process Engineer to assist engineers in setting up and conducting R&D development experiments and tests. He or she should be hands on in setting up experimental benchtops include setting up electrical dataloggers, sensors, pumps and actuators. The candidate should have basic mechanical knowlede so that they can setup the fluid circuit on the bench.

This position supports the development of water purification subunit to be used in a medical device application. The majority of time will be spent in laboratory preparing and testing water purification unit and functional component & sub-components. This position works under supervision of more experienced engineers and follows established procedures.

Main Responsibilities and Tasks:

  • Preparation of aqueous solutions, using standard laboratory equipment and techniques to handle solutions
  • Perform routine measurements and perform routine equipment calibrations as required
  • Set-up and operate testing equipment including data acquisition software
  • Collect and prepare samples for analysis; perform sample analyses using established procedures
  • Ability to maintain focus and attention to detail in setting up, executing and documenting chemical/analytical tests.
  • Proficiency with Microsoft Excel to perform data entry, modest data analysis such as basic graphs and summary statistics, and ability to format data as requested for export to other programs.
  • Proficient with standard test and measurement equipment, such as thermocouples and RTDs, pressure transducers, flow meters, conductivity cells, pH sensors, weight scales, and calipers.
  • Proficiency with Microsoft PowerPoint to create simple diagrams, figures, and schematics to document work performed. Basic familiarity with collecting data using Labview software.
  • Characterization of materials and functional sub-components using established testing methods
  • Development and optimization of chemical processes and associated test methods under the direction of engineers and scientists

Required Qualifications & Experiences:

  • BA/BS in Chemistry, Chemical Engineering or equivalent


Posted: July 1, 2020, 1:31 pm
Category : Electrical Engineer
Job Type : Contract
Id : 7931
Region : Twin Cities

The Senior Electrical Engineer provides electronics engineering expertise to the Supply Management organization and suppliers, serving as the technical liaison between company design requirements and suppliers' technical capability to assure that robust margins are achieved and maintained. Researches, develops, designs, and tests electrical components, equipment, and systems for a major medical device company's contract manufacturers & OEMs.

SPECIALIST CAREER STREAM:

  • 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).

DIFFERENTIATING FACTORS:

  • 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 and external contacts. Contacts others to share information, status, needs and issues in order to inform, gain input, and support decision making.
  • Specialized knowledge: Medical Device electronics and/or materials experience.

REQUIRED KNOWLEDGE AND EXPERIENCE:

  • B.S. in Engineering and 4 years of relevant experience.

PREFERRED KNOWLEDGE AND EXPERIENCE:

  • B.S. in Electrical or Electronics Engineering and 6 years of relevant experience.
  • Medical device manufacturing, including Validations & Verifications and Change Control.
  • Ability to take evening calls (7pm – 9pm Central) one to two times a week.


Posted: June 26, 2020, 12:09 pm
Category : Firmware Engineer
Job Type : Contract
Id : 7930
Region : Twin Cities

Looking for a Senior Firmware Engineer to join our R&D Organization to design and develop new and modifications to firmware for the cardiac ablation systems. The Senior Firmware Engineer will also be responsible for designing test systems or subsystems for testing the equipment. 

Areas of responsibilities will include firmware system design, software development in C, design requirements, test requirements and test procedures, PC-based simulation and test automation in C#.Candidates must be able to translate design inputs into firmware design, write detailed firmware specifications, generate and review design documentation, interface specifications, test specifications and test reports in compliance with design control procedures used within the medical device industry.  Candidates must also be willing to work in a fast paced, multi-tasking, team environment.

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

 

POSITION RESPONSIBILITIES

  • 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

  • 8+ years of embedded software design and development with Bachelors Degree in Engineering (Electrical or Software)
  • 6+ years of experience with Masters Degree or
  • 5+ years of experience with PhD
  • Embedded software development in C language
  • Strong experience working with hardware, including ability to read schematics, data sheets and interface specifications
  • 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: June 26, 2020, 6:51 am
Category : Packaging Engineer
Job Type : Contract
Id : 7927
Region : Twin Cities

The Packaging Engineer designs, develops, and tests a wide variety of containers used for the protection, display, and handling of Medical Device products. This position 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. Also 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: 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: June 23, 2020, 11:13 am
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 : Quality Engineer - Medical Device
Job Type : Contract
Id : 7920
Region : Twin Cities

The Quality Engineer develops, modifies, applies and maintains quality standards and protocol for processing materials into partially finished or finished materials product.  Collaborates with engineering and manufacturing functions to ensure quality standards are in place. Devises and implements methods and procedures for equipment qualification (EQ) and Test Method Validations (TMV). 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.

 

DIFFERENTIATING FACTORS:

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

 

Required Knowledge and Experience:

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


Posted: June 8, 2020, 8:49 am
Category : Technical Writer
Job Type : Contract
Id : 7913
Region : Twin Cities

The Technical Writer will develop complex technical materials (labeling) that instruct users in the safe and proper use of medical device products and therapies. The audiences for these materials include physicians, nurses, hospital technicians, and patients.

POSITION RESPONSIBILITIES:

  • Plan, research, develop, and write medical device labeling, and manage labeling deliverables as part of cross-functional project teams under general supervision.
  • Simultaneously manage up to two labeling updates and one small, new-product-introduction project that involves multiple labeling pieces.
  • Understand and adhere to all quality management system documents and product commercialization procedures applicable to labeling development.
  • Research and write requirements used to create labeling content, and write requirement trace reports.
  • Assist in providing documentation for CAPAs, and departmental and business-unit audits.
  • Contribute to time and cost estimates for labeling deliverables for project teams.
  • Develop illustrations in cooperation with professional illustrators.
  • Participate on department and business-unit initiatives.
  • Oversee Engineering Change Order process for labeling, including writing change control plans and presenting to the Change Control Board.
  • Coordinate translations with company translations and track the status of translations.
  • Prepare and occasionally present documentation for product issue escalation events, deviations and functional reviews.
  • Complete labeling proofs, develop documentation for regulatory submissions, and carry out other tasks as assigned.

POSITION REQUIREMENTS:

  • BA/BS in Technical Communications, English, Journalism, or related field and 1+ years of writing experience, or MA/MS in Technical Communications, English, Journalism, or related field.


Posted: May 26, 2020, 1:17 pm
Category : Reliability Engineer
Job Type : Contract
Id : 7904
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 for a major medical device company.

POSITION RESPONSIBILITIES:

  • 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.

POSITION REQUIREMENTS:

  • Education Required: Engineering degree, Bachelor's or Master's
  • Minimum 4 years relevant experience required


Posted: April 30, 2020, 8:59 am
Category : Technician - Medical Equipment
Job Type : Contract
Id : 7856
Region : Twin Cities

Immediate opportunity for an Automation Build Technician to support equipment build projects for medical device manufacturing.

 

The Technician will assemble, test, and troubleshoot custom automated equipment and work cells.  This includes electrical control panel wiring, motors, drive systems, mechanical enclosures, and PLC installations and check-out.

 

Preferred Skills:

  • 2 year degree in Electronics or Automated Systems Technology
  • Hands on experience with equipment build
  • Must be able to read prints, schematics, and work instruction
  • Strong mechanical and electrical aptitude
  • Ability to work independently within a custom automation group
  • Knowledge and experience with PLC, HMI, and motion control
  • Medical device development environment experience is a plus

 

Posted: February 28, 2020, 1:47 pm
Category : Software Engineer
Job Type : Contract-to-Hire
Id : 7788
Region : Twin Cities

The Principal Software Architect works with the Software Engineering team and has the prime responsibility of leading the company’s team of Software Engineers, including the formation of software architecture and development plans on projects requiring software/firmware.

Requirements:

  • A Bachelor’s degree in Computer Science/Engineering, coupled with 10+ years of experience in systems software development within the medical device arena is required along with the following key attributes:
  • Skilled in the art of software systems architecture for both embedded software and larger interconnected software systems
  • Experience leading software teams in a multi-disciplined environment
  • Ability to translate user needs and system design specifications and into software requirements
  • Experience designing and developing software and firmware applications in response to functional specifications
  • Experience using industry standard tools and practices to document and visualize software system architecture
  • Experience designing and developing embedded applications with intensive, interrupt driven communications for real-time process control applications using multiple serial channels and communications protocols (proprietary and standard based)
  • Experience in developing cloud software systems and mobile application software
  • Experience in developing wireless applications and devices
  • Experience in sensor and instrumentation integration
  • Experience creating software development plans and schedules
  • Extensive use of debugging tools, including software debuggers and basic use of electronic diagnostic devices for software development, integration, debugging, and troubleshooting
  • Integrate firmware with a variety of hardware platforms and to analyze and troubleshoot the hardware/firmware interface
  • Prefer Certified Cloud Solutions Architect (AWS or Azure)
  • Experience with ISO 13485, IEC 62304, FDA design controls or similar regulatory environment

Our fast-paced environment demands the ability to manage multiple projects within various disciplines and deadlines. High-energy, self-starters with the following qualities:

  • Successful communication skills, business acumen and assertive decision-making ability
  • Flexibility to multi-task and perform a wide range of activities
  • Excellent computer skills, including MS Office proficiency

Responsibilities:

  • Work with the greater development team, including Systems Engineering, to develop high level software requirements
  • Design, develop and document software systems architecture for projects ranging from small embedded systems to larger interconnected systems.
  • Support the software development team with translating high level software requirements into detailed software requirements, supporting the documented software architecture
  • Verify that the documented architecture is implemented according to plan through participation in code reviews and design reviews throughout the process
  • Dictate design choices to software developers, including, but not limited to: platforms, coding, and technical levels
  • Create project software development plans, which may favor either a waterfall or agile development process.
  • Work with the program management team on creating accurate software project schedules
  • Maintain and continually improve the software architecture and development process, as technologies and teams evolve
  • Design and develop firmware for embedded systems. Integrate developed applications with other components
  • Mentor junior staff and serve as software onboarding liaison for new employees
  • Assist hardware engineers in development of new platforms and in troubleshooting hardware/software interfaces
  • Document and perform integration, testing, debugging and installation support and activities
  • Participate with project team in the design and implementation of new and enhanced products
  • Develop control algorithms to optimize module and display system performance
  • Interface with design team to support functional test and measurement requirements
  • Initiate and maintain FDA software design control documents
  • Support the manufacturing process by designing and developing production automation software


Posted: November 11, 2019, 8:51 am
Category : Mechanical Designer
Job Type : Contract
Id : 7778
Region : Twin Cities

The Mechanical Designer will be responsible for design of special machines, fixtures, and automated production equipment.

Prefer a 2 year degree in mechanical design and 5 to 10+ years of hands on automated equipment design experience, from concept through detailed design.

Requirements include strong SolidWorks design skills, and experience in one or more of the following areas: product packaging or assembly equipment, dial and indexing systems, robotics, motion control, for manufacturing equipment. Ability to specify components, drives, material handling systems, pneumatics, and related automation components is required, and experience with medical / pharmaceutical equipment design preferred.



Posted: November 5, 2019, 12:50 pm
Category : Technicians
Job Type : Contract-to-Hire
Id : 7776
Region : Twin Cities

Seeking a Production Technician to support 3D or 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 : Firmware Engineer
Job Type : Permanent
Id : 7766
Region : Twin Cities

We are currently hiring an Embedded Linux Software Engineer to develop embedded software for new products and maintain existing product lines through improvement updates. Preference is someone experienced working with open source tools as well as traditional embedded software technologies used in a regulated environment for medical devices.

Responsibilities:

  • Development of C/C++/C++ v11 embedded software applications for both new and existing medical devices
  • Adapt and extend existing embedded Linux applications to add new features to current products, analyze the existing architecture and if applicable, adjust and extend it to allow reuse across additional future products.
  • May coach and develop entry level engineers by sharing knowledge and best practices
  • Assist in planning, estimating, and scheduling software development efforts
  • Review, and guide technical work and issue resolution providing multiple options and ensuring that all work meets requirements and specifications in compliance with the quality system and best practices
  • Maintain frequent communication within and outside of the department in support of engineering activities and project plans
  • Assure appropriate documentation for assigned project
  • Understands and follows requirements of SOPs.
  • Contribute to corrective action development and alternatives.
  • Determine resolution of intermediate technical issues as needed and assures that technical work meets specified requirements.
  • Conducts testing for assigned projects.
  • Prepare documentation associated with engineering activities.
  • Conduct design testing.
  • Operate with a significant amount of latitude and freedom. Within these minimal constraints, may lead medium to large projects; plans and authorizes tests and approves test evaluations; directs and approves documentation and related drawings; designs components, parts or systems of significant difficulty; oversees/approves troubleshooting resolutions.
  • Perform engineering work requiring full competency in all conventional aspect of engineering
  • Plans and conducts work requiring judgment in the independent evaluation, selection and the substantial adaption of standard engineering techniques, procedures and requirements. Plans and coordinates detailed phases of engineering actions for part of a project
  • Performs assignments independently troubleshooting tasks as related to product problems.
  • Performs assignments independently with limited supervision as to expected results.
  • Independently plans, schedules, conducts or coordinates detailed phases of the assigned project.
  • Continuously reviews project team progress and evaluates results accordingly.
  • Works under only general supervision, with direction given only in terms of broadly stated objectives and desired outcomes.

Requirements:

  • Minimum Bachelor's degree in engineering or similar. Software or Electrical Engineering preferred
  • 3-5 years of experience or 2-5 years with an advanced degree.
  • 3+ years of Embedded Linux experience (Buildroot or similar)
  • Experience writing C and C++ applications running on Linux, RTOS, bare metal, uCOS, or similar
  • Experience working with UI frameworks such as Qt, Altia or similar
  • Able to write clean, safe, readable code
  • Applies extensive technical expertise in the engineering field and has knowledge of other related disciplines (Global Product Management, Quality, Regulatory, Sales and Operations)
  • Work under only general supervision from the Engineering Manager, with direction given only in terms of broadly stated objectives and desired outcomes
  • Ability to clearly convey ideas and concepts verbally and in writing

Preferred Requirements:

  • Experience in regulated product development environments preferred
  • Experience in multiple areas of an embedded device (UI, communications, databases, drivers, OS) through all stages of the development process, including for example, requirements, architecture design, coding, test, documentation, and safety analysis highly preferred
  • Experience developing and debugging complex software systems highly preferred
  • Experience planning, scheduling, and conducting multiple phases of a software project highly preferred
  • Experience working in an Agile development environment using tools such as Git, Jira, TFS, etc.
  • Experience in python and bash scripting and creating automated test frameworks preferred
  • Experience coaching and mentoring others in technical matters and related project initiatives preferred
  • Strong influencing skills and ability to convey clear supporting evidence for proposals
  • Ability and willingness to lead and create changes in policy, procedure, technology, and culture


Posted: October 16, 2019, 7:24 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 : Quality/Regulatory
Job Type : Contract
Id : 7756
Region : Twin Cities

Seeking a detail-oriented, proactive Certification Project Manager to run numerous certification projects.  Project coordination entails being main point of contact for customer, arranging certifications with test labs,

 

Position Description:

  • Work with test labs and other certification experts to determine what is needed to be able to certify current Company products for sale in counties outside of North America and Europe
  • Gather certification quotes from test labs and estimate support labor for potential certification projects.
  • Writing statement-of-work documents, which function as project proposals
  • Consult with internal Company employees to find test reports, product information, and any other information or help needed to complete new country certifications for existing Company products
  • 30+ hours per week
  • Certification/regulatory experience required

 

Posted: September 26, 2019, 1:24 pm
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 : Mechanical Engineer
Job Type : Contract
Id : 7657
Region : Twin Cities

 

Looking for a Mechanical Engineer to design medical devices to comply with industry methodologies and standards.  This candidate will define requirements, technologies, and methodologies for individual projects.  Research and analyze data such as experimental data, customer design proposals, specifications, and documentation.  Direct and coordinate actions from product conception through design transfer to ensure products and systems conform to engineering design, standards and customer specifications.  Resolve technical issues and problems.  Effectively communicate their work and status.  Delegate work and leverage engineering technicians and designers.

 

Requirements:

  • 3+ yeas of leading product design development.
  • 7+ years of direct experience with the product development process ranging from requirements development, prototyping, verification and product release.
  • Experience in medical device design or other regulated industries
  • 7+ years of leading/contributing completion of DHF document deliverables.
  • 7+ years of working in development of devices regulated under IEC 60601-1 standard
  • 3+ years working under ISO 14971 Risk Management for Medical Device Standard

 

Strong Candidate in addition to requirements:

  • 3+ years of planning, assigning, and directing work
  • Responsible appraising performance
  • 3+ years in contract manufacturing environment

 

Duties and Responsibilities:

  • Strong analytical and problem solving background.
  • Works with suppliers and manufacturing facilities to design for manufacturability.
  • Identifies and efficiently resolves technical problems and issue.
  • Leads and communicates to a client for small scale programs.
  • Researches and analyzes experimental data to understand design issues and set a direction for issue resolution.
  • Delegates and sets work direction for technicians and designers.
  • Creates test protocols and reports for verification testing.
  • Proficient in CAD (Solidworks preferred), Labview and general test and measurement equipment preferred.
  • Able to complete engineering tasks in a timely fashion, and manage time budgets for tasks.
  • Effectively communicates project technical status, time and schedule for tasks including estimates to complete.
  • Proficient with documentation control and change order process.

 



Posted: May 14, 2019, 11:46 am
Category : Test Engr - Technical
Job Type : Permanent
Id : 7626
Region : Twin Cities

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

Major Areas of Accountability:

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

Education and Experience:

  • Bachelor’s Degree in Electrical Engineering, Computer Science or equivalent experience in a test engineering environment
  • 5 – 10 years of work experience using TestStand and LabVIEW
  • CLD or CLA is preferred
  • Ability to design TestStand or LabVIEW architectures based on system requirements
  • Application software development skills in Microsoft Visual Studio (VB.NET/C#). C/C++ experience a plus
  • Analyze existing test solution (electrical/software) and understand the design for maintenance or updating/upgrading test software
  • Solid analytical skills; able to resolve technical problems with innovative solutions
  • Proven ability to manage working on multiple projects at a time while paying strict attention to detail
  • Proficiency with Microsoft Office Suite
  • Effective verbal and written communication skills
  • Capacity to deal with a high workload and deadline pressure
  • Requires a strong initiative, proactive nature and a sense of urgency
  • Ability to travel 0% - 10% to client locations for meetings and/or system installations
  • Ability to work extended hours as necessary to meet deadlines
  • Must be able to perform in a team environment with good interpersonal skills with commitment to the highest quality achievable
  • Maintains confidentiality and security of intellectual property (ITAR, Prototype)


Posted: April 4, 2019, 12:07 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 : Software Engineer
Job Type : Contract
Id : 7548
Region : Twin Cities

 

Essential Job Functions & Responsibilities:

  • Embedded firmware design and implementation
  • Support projects for new and existing customers. This will require theoretical analysis, simulation analysis, software/firmware implementation, code review, documentation, and hardware/software integration testing.
  • Support communication protocol development efforts: network security protocols, wireless mesh networking and network security
  • Support development in multiple operating systems:  Linux, FreeRTOS, bare metal, Windows, etc.
  • Coordinate and work collaboratively cross functionally as well as with other software development teams in the organization
  • Lead software efforts being self-directed as well as leading small software teams
  • Mentor junior engineers in current trends and best practices
  • Provide outstanding documentation of software designs
  • Assist with certification testing
  • Coordinate software releases with internal and external stakeholders
  • Participate in appropriate training and development programs to maintain and enhance job-related skills

 

Required Qualifications:

  • Minimum: BS or MS in Computer Engineering, Electrical Engineering or Computer Science
  • 10+ years of related experience
  • Direct experience in programming in C for real-time embedded systems
  • Significant experience working with 32-bit microcontrollers in a flash and RAM constrained system
  • Significant experience with microcontroller peripherals and interfaces: UART, SPI, ADC, PWM, Timers, etc.
  • Development experience with embedded Linux (layers below application) and RTOS/bare metal
  • Skilled in the use of test and debug equipment: oscilloscopes, logic analyzers, multi-meters, spectrum analyzers, etc.
  • Demonstrated ability to function self-directed in leading software engineering efforts
  • Demonstrated ability to lead a small team of software engineers, i.e. task planning/managing, mentoring, defining core architecture, etc.
  • Good communication and team skills, both externally and internally
  • Solid debugging, troubleshooting, and problem solving ability
  • Eagerness to collaborate with team members and coworkers within the organization
  • Solid experience in delivering quality documentation (Requirements, Design Doc's, test plans)
  • Experience working through all phases of software development (Concept, architecture, development, test, release to manufacturing)

 

Preferred Qualifications:

  • Experience in developing Linux Kernel drivers, and low level Linux protocols
  • Experience in developing in real-time operating systems
  • Experience with RF communication
  • Experience with RF protocols at the PHY/MAC/NWK layers such as 802.15.4, zigbee, BLE, or Wi-Fi
  • Experience with networking protocols
  • Experience with a revision control system, GIT is preferred
  • Python experience
  • Experience with unit testing


Posted: November 20, 2018, 11:57 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