Role OverviewThe Sr Design Assurance Engineer provides focused quality engineering leadership on sustaining design assurance activities, including quality plans, risk management plans, and reports.
What You Will Do
This role will be responsible for supporting risk document and post market record review during remediation activities, as well as ensuring quality and compliance through post commercialization sustaining activities.
Why It Might Be a Fit
The ideal candidate will have a strong understanding of electrical safety standards IEC 60601, experience with reliability testing, and demonstrated use of Quality tools/methodologies.
Requirements
- Bachelor’s degree in mechanical, electrical, biomedical engineering, or related discipline
- 5+ years of related experience in design assurance, new product development, or related medical device or regulated industry experience
- Understanding of electrical safety standards IEC 60601
- Experience with reliability testing
- Demonstrated use of Quality tools/methodologies
- Strong written/verbal communication skills
- Risk documentation per ISO14971
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