Senior Design Assurance Engineer

Our client is a medical device organization developing innovative, catheter-based therapies supported by a regulated quality system. The team partners cross-functionally to bring new products from development through production launch, while maintaining strong design controls, risk management practices, and global regulatory compliance expectations.

In this role, you will support product development activities to enable a successful production launch and sustained delivery of high-quality products, while partnering with Engineering, Operations, Quality, Marketing, and Regulatory to execute design control, documentation, and compliance deliverables.

• Execute and support completion of product development deliverables across the design lifecycle
• Create and maintain Design History File documentation to ensure completeness, accuracy, and regulatory compliance
• Support development and maintenance of customer requirements, product requirements, and product specifications
• Lead and support completion and maintenance of product risk management deliverables through cross-functional collaboration
  
  Author design verification and design validation plans and reports
• Implement sampling inspection approaches and support qualification activities for purchased components
• Support design test method development and lead test method validation activities
• Apply statistical techniques to support characterization, verification, and validation testing and root cause analysis
• Support quality system deliverables, including nonconformances and CAPAs
• Perform other related duties and responsibilities, as assigned

• BS in Engineering or related technical discipline
• 5+ years of experience in Engineering or Quality within the medical device industry
• Strong working knowledge of design controls and DHF documentation practices
• Experience authoring and executing verification and validation plans, protocols, and reports
• Experience supporting or leading risk management activities aligned to ISO 14971
• Experience with test method development and validation
• Proficiency with quality systems fundamentals and good documentation practices
• Experience investigating nonconformances and implementing CAPA
• Working knowledge of FDA 21 CFR, EU MDR, Australian TGA, and ISO 13485
• Strong written and verbal communication skills with cross-functional collaboration capability
• Ability to work independently with limited supervision

• Competitive salary plus a comprehensive benefits package.
• Health coverage, retirement plans, and other company-sponsored perks.
• Generous paid time off, including holidays, to support work-life balance.
• Flexible schedules and work life balance.
• Strong focus on employee development with on-the-job training and career growth.
• A positive company culture that values diversity and collaboration.

The pay range for this role is: 105, USD per year (Minneapolis, MN)