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.
Key Responsibilities - 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
Requirements