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    Design Assurance Engineer - St Paul, United States - Novozen Healthcare LLC

    Novozen Healthcare LLC
    Novozen Healthcare LLC St Paul, United States

    1 month ago

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    Description
    : Guides the design control process for product development projects. Owns the risk management file and works with the R&D team to perform risk assessment for product design and manufacturing processes. Writes risk management plans, quality plans, verification plans, and may author associated reports. Supports design verification activities, including management of biocompatibility testing, and packaging validation testing. Reviews, provides feedback, and approves project design and development deliverables as the quality lead. Performs risk and impact assessments for design changes to products.

    Hit Apply below to send your application for consideration Ensure that your CV is up to date, and that you have read the job specs first.

    Must:

    • 5 years+ medical device experience
    • Sterilization experience
    • Packaging validation
    • DHF experience
    • E- Bean Sterilization (ask consultant if they have experience with it
    • ISO and if they have recent sterilization experience, they will have experience with both of those)

    Plus

    • VHP experience ( Close enough to E- Beam that if they have VHP and no E- Bean experience, she would be open to talking to them)
    • Biocompatibility

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