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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