Lead V&V Engineer

Role & responsibilities

1. Lead and manage the entire Verification & Validation process throughout the product development lifecycle, ensuring alignment with regulatory and design control requirements.
2. Execute verification and validation activities across mechanical, hardware, software, and system levels.
3. Develop V&V documentation including test plans, protocols, reports, and traceability matrices.
4. Perform hands-on testing, analyze results, and ensure traceability to design inputs and risk mitigations.
5. Ensure compliance with applicable standards and regulations such as ISO 14971, IEC 62366,  IEC 60601 series and device particular standards.
6. Plan and conduct clinical validation activities in hospital settings, including protocol development, coordination with clinical staff, and data analysis.
7. Collaborate with cross-functional teams (R&D, Regulatory, Quality, Manufacturing) to support design control and product development lifecycle.
8. Identify root causes for field issues and test failures, and implement effective corrective and preventive actions (CAPA) to improve product design and reliability.
9. Participate in design reviews and contribute to test strategy, risk assessments, and technical decisions.

Preferred candidate profile

• Bachelors degree in Biomedical Engineering, Mechanical/Electrical Engineering, or a related field.
• 4-5 years of experience in V&V engineering for medical devices.
• Hands-on experience in writing and executing test protocols.
• Solid understanding of IEC/ISO standards, with working knowledge of IEC 60601-1 and experience in electrical safety and performance testing for medical devices.
• Experience collaborating with accredited third-party testing laboratories for regulatory compliance.
• Strong analytical, documentation, and problem-solving skills.
• Ability to work independently and in cross-functional teams.