A medical device client of ours is seeking a Senior Design Assurance Engineer to join their team on a permanent basis. Candidates must have a medical device background within design controls for this role. This role is hybrid!
Job Title: Senior Design Assurance Engineer
Location: Minneapolis, MN
Salary : 90-125k + 15% bonus, depends on experience
Key Responsibilities
- Participate in New Product Development Phase Reviews; lead/participate in Design Reviews.
- Partner with R&D to determine and define design inputs, design outputs, and design input/output relationships.
- Review and support Electrical and Software Design Inputs, Design Verification and Test Readiness Reviews
- Work with R&D team and 3rd party software/electrical consultants to complete project deliverables
- Ensure relevant design standards are appropriately applied and satisfied. Create and support the development and validation of new test methods.
- Determine and document risks (Hazard Analysis, DFMEA, PFMEA, UFMEA).
- Support the execution of design verification and validation, as well as usability.
- Generate/support test protocols, manage test execution, investigate test issues, analyze data, and create reports for design verification and validation testing, including shelf life and stability.
Requirements
- BS in Engineering (Electrical or Software Engineering preferred)
- 3-5 years related experience and/or training in design assurance
- ASQ Certified Quality Engineer preferred
Benefits
- Hybrid role, 3 days in office
- Unlimited PTO
- Medical, Dental, & Vision with HSA and FSA plans
- Retirement plans including a 401K match
- Supplemental Life Insurance & Disability Plans
- ESOP
If this is a role that interests you and you’d like to learn more, click apply now and a recruiter will be in touch with you to discuss this great opportunity. We look forward to speaking with you!
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