Overview In this role you will drive design quality activities for legacy products within a medical device company that values patient focus and integrity. You will partner with Operations, R&D, and Supply Chain to improve products and processes while ensuring regulatory compliance. The position blends design control, risk analysis, and production release leadership to deliver compliant, high-quality devices. This is a hybrid, Minnesota-based role offering meaningful impact across cross-functional teams.
Compensation / Benefits- Competitive salaries
- Annual bonus
- 401(k) with company match
- Medical/dental/vision coverage
- Paid vacation and sick time
- Paid parental leave and adoption assistance
Responsibilities- Lead Production Release Process projects for components and finished devices
- Drive complex quality improvement initiatives and cross-functional alignment
- Coordinate Design Control activities for new product development
- Lead Process/Design Risk Analysis and risk management activities
- Support Process/Design Validation and software validation approaches
- Implement cost of quality concepts, data collection and reporting
- Assist Manufacturing Engineering with DMR, DHR, BOMs, and print/spec changes
- Ensure compliance with laws, policies, and professional conduct
Key requirements- Bachelor's Degree in Engineering
- 5+ years quality engineering experience in FDA-regulated medical device manufacturing
- Strong problem-solving using Six Sigma tools for root-cause analysis
- Experience with Sustaining Engineering, post-market support, and regulatory requirements (FDA QSR, ISO 13485, ISO 14971, ISO 11135, EU MDR)
- Statistical knowledge and experience with Minitab
- Risk management, CAPA, and regulatory compliance skills
- Excellent written and oral communication; able to work in fast-paced environment
- Ability to travel up to 10%
- Strong communication skills
- Cross-functional collaboration
- Prioritization and multi-tasking
- Six Sigma problem solving
- Process/Design Validation and Verification
- Risk Management (ISO 14971)
