Senior Design Assurance Engineer

We are partnering with an established medical device manufacturer to hire a Senior Design Assurance Engineer to support new product development and sustaining engineering activities within a regulated medical device environment.

• Serve as the Design Quality representative for new product development and sustaining projects
• Lead and facilitate Design Control and Risk Management activities throughout the product lifecycle
• Drive Design Verification & Validation (V&V), process validation, usability studies, and test method validation
• Conduct risk assessments including Hazard Analysis, Risk-Benefit Analysis, dFMEA, and pFMEA
• Ensure compliance with ISO 13485, ISO 14971, FDA QSR, and applicable regulatory requirements
• Develop and maintain quality documentation, SOPs, and QMS records
• Support internal, supplier, and external audits

• Degree in...