V&V Engineer

Job Summary:

• The System Verification & Validation (V&V) Engineer is responsible for executing system-level verification and validation activities to ensure requirements traceability, regulatory compliance, and generation of objective evidence for design releases and sustaining changes in regulated medical device environments.

• Execute system-level Verification & Validation (V&V) activities.
• Develop and execute V&V Plans, Protocols, and Reports.
• Maintain requirements traceability and Design History File (DHF) documentation.
• Perform hardware, software, and laboratory testing.
• Ensure compliance with ISO 13485 standards.
• Communicate project status and present objective evidence during design and review meetings.
• Implement and support test automation for regression and system-level testing.

• Bachelor's or Master's degree in Engineering (Electrical, Biomedical, Mechanical, or Software).
• 7 10 years of experience in system-level V&V for IVD/medical devices or complex electromechanical systems.
• Hands-on experience in protocol design and execution in regulated environments.
• Experience in test automation.
• Preferred experience with wet lab workflows, including sample handling and reagents.
• Familiarity with ISO 13485, ISO 14971, and IEC 62304 standards.