In this role, you will build the V&V team from the ground up, define methodologies and best practices, and lead end-to-end verification and validation activities for complex multidisciplinary medical systems. You will work closely with cross-functional teams including System Engineering, Software, Hardware, Mechanical Engineering, Quality, Regulatory Affairs, Clinical, Operations, and Manufacturing to ensure the delivery of high-quality, compliant products.
Responsibilities:
• Build, lead, and mentor a growing V&V team
• Define and implement V&V methodologies, processes, and testing strategies
• Lead verification and validation activities for complex medical devices combining multiple technologies
• Develop and execute validation plans, test protocols, and traceability documentation
• Ensure compliance with global medical device regulations and standards
• Drive continuous improvement in testing methodologies, automation capabilities, and quality processes
• Support the entire product lifecycle, from development through manufacturing transfer and post-market activities
• Collaborate with Operations and NPI teams to ensure successful manufacturing validation
• Manage external certified laboratories for safety, EMC, and environmental compliance testing
