Sr. Design Assurance Engineer
$110,000–$127,500 year
On-siteMinneapolis, Minnesota, United States
Job Summary
Execute design control activities for assigned product development programs ensuring compliance with ISO 13485:2016, QMSR (21 CFR Part 820), and other regulatory requirements. Develop, execute, and document verification and validation protocols and reports while supporting design transfer activities to enable successful commercialization. Conduct product risk management activities across the lifecycle from concept through post-market surveillance, including hazard identification, risk analysis, and implementation of mitigation strategies. Partner with R&D, Regulatory Affairs, Clinical, and Manufacturing teams to align on design, quality, and compliance requirements throughout product development and commercialization. Support the resolution of product and quality issues through data-driven analysis, root cause identification, and corrective and preventive actions.
Required Qualifications
- Bachelor's degree in Engineering, Life Sciences, or related field, or equivalent experience
- 3 to 5 years of experience in medical device design quality assurance or a closely related engineering role
- Working knowledge of design controls, risk management, and regulatory compliance
- Working knowledge of design control requirements, including QMSR (21 CFR Part 820), ISO 13485, and risk management under ISO 14971
- Experience writing and executing verification and validation protocols and reports
- Ability to evaluate technical data and support sound, risk-based decisions
- Strong collaboration and communication skills across cross-functional teams
- Self-directed and motivated; seeks out work, takes ownership, and follows through in a fast-moving, high-growth environment
Desired Qualifications
- Experience with catheter-based or vascular devices
- Exposure to Class III devices and PMA pathways
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