• Senior Staff Scientist - Process Development…

    Mayo Clinic (Rochester, MN)
    …operations supporting approved standard operating procedures (SOPs) and product validation for FDA -regulated, cGMP compliant manufacturing operations. ... in a compliant manner. Participates in drafting regulatory documentation for FDA submission. Participates in forecasting project budgetary needs. Guides the… more
    Mayo Clinic (03/16/25)
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  • Senior QA Validation Engineer

    Danaher Corporation (Chaska, MN)
    …tools that address the world's biggest health challenges. The Senior QA Validation Engineer for Beckman Coulter Diagnostics is responsible for assisting in the ... sustainment of a robust Master Validation Plan and support of the MVP strategies. This...equipment, process, and/or design testing methodologies. + Knowledge of FDA regulations, ISO standards, and GxP guidelines. + Experience… more
    Danaher Corporation (04/26/25)
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  • Quality Engineer

    Actalent (Brooklyn Park, MN)
    …Skills in other technical areas such as verification testing, and sterilization validation are desired. Engage in routine daily activities such as First Article ... and effectiveness. - Participate in the development of Design Verification and Validation test plans / protocols and Process Verification and Validation … more
    Actalent (04/30/25)
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  • Quality Engineer

    Actalent (Minneapolis, MN)
    …Provide guidance on sample size and statistical methods for Verification and Validation testing. + Continuous Improvement: Engage in activities to improve processes ... Reviews. Documentation and Compliance: + Develop and review Design Verification and Validation test plans/protocols and Process Verification and Validation test… more
    Actalent (05/01/25)
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  • Sr. / Principal Design Assurance Engineer…

    LCI-Lawinger Consulting (Minneapolis, MN)
    …role offers an exciting opportunity to contribute to the development and validation of innovative medical devices in a collaborative, fast-paced environment. As a ... throughout the product development lifecycle, ensuring compliance with regulatory standards ( FDA , ISO, etc.). + Review and approve design documentation, including… more
    LCI-Lawinger Consulting (05/08/25)
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  • Sr. Risk Management Specialist

    Medtronic (Fridley, MN)
    …deliverables to include Product Performance Specifications, Design Verification, Design Validation , Design Transfer, and Usability and Human Factor Engineering; ... provide support for Variable and Attribute Test Method Development and Validation . Provide support for Complaint and Product Failure Investigations, pre and… more
    Medtronic (04/01/25)
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  • Principal Quality Engineer

    Actalent (Maple Grove, MN)
    …to risk management (in accordance with ISO 14971), design verification and validation (aligned with EN ISO 5840-1/-2/-3), and quality management systems. Skills ... Design assurance, Iso 13485, Design control, Risk management, Design validation , Validation , Quality engineering Top Skills Details...CE Marking, EN ISO 5840, EU MDR (formerly MDD), FDA Medical Device Regulation (MDR), and FDA … more
    Actalent (04/26/25)
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  • Quality Engineer

    Actalent (Brooklyn Park, MN)
    …customer, and internal standards. Skills in verification testing and sterilization validation are desired. Engage in routine activities such as First Article ... and effectiveness. + Participate in the development of Design Verification and Validation test plans/protocols and Process Verification and Validation test… more
    Actalent (05/07/25)
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  • Sr. Manufacturing Engineer

    Medtronic (Brooklyn Center, MN)
    …Center, MN. Complete equipment and process changes and navigate in an FDA regulated environment, ISO 13485 & GMP. Design, evaluation, installation, operation, ... including electrical controls, pneumatics, and PLC. Installation, qualification, and validation (IQ/OQ/PQ) of manufacturing equipment and processes including resistance… more
    Medtronic (05/05/25)
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  • Distinguished Automation Engineer

    Medtronic (Fridley, MN)
    …for establishing best practices and standards for the design, development, and validation of automation systems. Beyond technical execution, this role will drive ... with broader business and operational objectives. Familiarity with regulated environments ( FDA , GMP, ISO 13485) and awareness of Industry 4.0 technologies (IIoT,… more
    Medtronic (05/03/25)
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