Senior Design Assurance Engineer

  • High Growth Medical Company via The Walstrom Group, Inc.
  • Minneapolis, MN, USA
  • Apr 27, 2021
Engineering

Job Description

The Sr. Design Assurance Engineer will be responsible for leading design assurance activities throughout the product lifecycle process from concept to commercialization. The role works cross functionally to ensure compliance with Client's quality system, helps lead risk management activities, owns design verification testing, and supports the transfer of design to production. DUTIES AND RESPONSIBILITIES:Own the risk management files and work with R&D team to do the risk and benefit analysis for the projectOwn the risk and impact assessment (risk management or verification testing impact) for design changes to products.Owns design verification activities including planning, test execution, and documentation of results.Co-own (with project manager) the processes and documentation for design review, DHF content structure and project phase gate releases.Assure DHF clearly documents the trace between design input, design implementation and design output.Assure verification test protocols and reports properly trace all product requirements to an associated confirmation test.Assures verification readiness by overseeing device build documentation and equipment qualification activities.Approve and provide input to the regulatory plan per the requirements from the regulations and customer.Approve and provide input to the manufacturing controls (inspection and test procedures and pFMEA) for the projectApprove the verification and validation protocol for the project.Approve DFM (design for manufacturing) design reviews.Approve design transfer protocol and reports for the project. RequirementsMinimum Education:· Bachelor's in Life Science discipline or equivalent combination of education and experience.Minimum Experience:· 5+ years medical device design assurance experience in single use devices, including catheters and introducers

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