Validation and Verfication Engineer

Job Summary

We are looking for an experienced Verification & Validation (V&V) Engineer with 6+ years of hands-on experience in the medical device industry. The ideal candidate will be responsible for planning, developing, executing, and documenting verification and validation activities throughout the medical device product development lifecycle.

The candidate should have strong knowledge of medical device development processes, design controls, risk management, test methodologies, and regulatory requirements, with proven experience in preparing and reviewing technical documentation.

Key Responsibilities

• Develop and execute Verification & Validation strategies, plans, protocols, and reports for medical device products.
• Define verification methods, acceptance criteria, test requirements, and traceability based on product specifications and user requirements.
• Prepare and review V&V protocols, test cases, test procedures, test reports, and summary reports.
• Execute and coordinate design verification and validation testing for medical devices and associated systems/components.
• Establish and maintain Requirements Traceability Matrix (RTM) linking user needs, system/product requirements, design inputs, and verification/validation evidence.
• Work closely with R&D, Systems Engineering, Quality, Regulatory, Manufacturing, and Clinical teams to ensure V&V activities are completed as per project timelines.
• Support risk management activities in accordance with applicable medical device standards and procedures.
• Review design changes and assess their impact on existing verification and validation activities.
• Support verification of software, hardware, mechanical, electrical, and system-level requirements, as applicable to the product.
• Identify, investigate, document, and support resolution of test failures, non-conformances, and deviations.
• Ensure V&V documentation complies with internal procedures and applicable regulatory requirements.
• Participate in design reviews, risk reviews, test readiness reviews, and technical discussions.
• Support internal, customer, and regulatory audits by providing V&V documentation and technical evidence.
• Contribute to continuous improvement of V&V processes, test methodologies, and documentation practices.

Required Skills & Experience

• 6+ years of relevant experience in Verification & Validation of medical devices.

• Strong understanding of the Medical Device Product Development Lifecycle and Design Control processes.

• Experience in developing and executing verification and validation protocols and reports.

• Strong understanding of requirements management and traceability.

• Experience with risk management and risk-based verification approaches.

• Knowledge of applicable medical device standards and regulations such as:

• ISO 13485

• ISO 14971

• IEC 60601, where applicable

• IEC 62304, for medical device software, where applicable

• IEC 62366, where applicable

• FDA 21 CFR Part 820 / applicable QMS requirements

• Good understanding of Design Verification (DV) and Design Validation (PV) activities.

• Experience in test planning, test execution, defect/failure analysis, and test documentation.

• Strong analytical, problem-solving, and technical documentation skills.

• Ability to work effectively in a cross-functional and multidisciplinary environment.

• Good written and verbal communication skills.