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Senior Design Assurance Engineer
2 months ago
A leading medical device company is seeking a highly skilled Senior Design Assurance Engineer to join their team. The ideal candidate will have a strong background in medical device design controls and a proven track record of ensuring product quality and safety.
Key Responsibilities:- Participate in New Product Development Phase Reviews and 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.
- BS in Engineering (Electrical or Software Engineering preferred)
- 3-5 years related experience and/or training in design assurance
- ASQ Certified Quality Engineer preferred
- 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
ManpowerGroup, the parent company of Experis, is a leading global workforce solutions company that helps organizations transform in a fast-changing world of work. We develop innovative solutions for hundreds of thousands of organizations every year, providing them with skilled talent while finding meaningful, sustainable employment for millions of people across a wide range of industries and skills.