Verification & Validation Specialist

Roles and Responsibilities :

• Develop and maintain V&V strategy, plans, and protocols for ventilator systems in compliance with regulatory and quality standards.
• Define test methodologies for system-level, subsystem-level (hardware, software & mechanical), and component-level verification and validation.
• Lead execution of functional, safety, and performance testing across all system layers.
• Analyze test results, identify deviations, and drive resolution through root cause analysis and corrective actions.
• Provide V&V input during design transfer and manufacturing readiness reviews.
• Document test outcomes, traceability, and compliance evidence in accordance with :
• FDA 21 CFR Part 820.30 (Design Controls)
• ISO 13485 (Quality Management Systems)
• ISO 14971 (Risk Management)
• IEC 60601 / ISO 80601 (Medical Electrical & Respiratory Devices)
• Maintain audit-ready documentation including test protocols, reports, traceability matrices, and defect logs.
• Support regulatory submissions by providing V&V documentation and technical justifications.
• Collaborate with design, systems, software, mechanical, and quality teams to ensure testability and coverage.
• Participate in design reviews, risk assessments, and change control boards.
• Proficient in V&V tools, requirement management platforms like IBM DOORS, and lifecycle tools such as HP ALM.

Education & Skills preferred :

Job Location-Pune

Notice Period- upto 45 days