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.

Position Responsibilities:

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

Position requirements:

• 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

Reasons to Apply:

• 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.