Design Assurance Engineer

4 weeks ago


White Bear Lake, United States Novozen Healthcare LLC Full time

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.

Must: 5 years+ medical device experience Sterilization experience Packaging validation DHF experience E- Bean Sterilization (ask consultant if they have experience with it ISO 11607-1 and 11607- 2 (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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