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Woburn

    Design Assurance Engineer- Medical Device - Woburn, United States - CEI Group

    CEI Group
    CEI Group Woburn, United States

    3 days ago

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    Description
    Design Assurance Engineer


    Responsibilities:


    Ensuring that the design process complies with relevant regulations and standards such as FDA guidelines, ISO standards, and other applicable regulatory requirements.

    Working with the verification and validation efforts to ensure that the product meets design specifications and user requirements.
    Working with documentation related to design inputs, outputs, reviews, and changes to ensure traceability and compliance with regulatory requirements.

    Working closely with cross-functional teams including R&D, manufacturing, quality assurance, and regulatory affairs to ensure alignment and collaboration throughout the design process.


    Qualifications:
    Demonstrated track record with 21 CFR 820, ISO 13485, or equivalent quality regulations.
    Organize system level DHF's (Design History Files)
    Help setup IVD (In Vitro Diagnostic) medical device design process.
    Proficient with the generation and execution of qualifications, validation protocols, and quality assurance procedures
    Knowledge of Class 1 medical devices preferred.
    A minimum of 5+ years of working experience in regulated manufacturing (e.g., IVD, Medical Device, Automotive, etc.) is required.
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