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:- MTech / ME / BE / BTech in Biomedical, Electrical, Mechanical, or Systems Engineering. - 3–6 years of experience in V&V for medical devices. - Experience with ventilators, CPAP, BiPAP, or similar life-support systems is highly preferred. - Strong understanding of design controls, risk management, and regulatory frameworks. - Experience with test development, execution, and documentation in a regulated environment. - Strong analytical, documentation, and communication skills.Job Location-PuneNotice Period- upto 45 days

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