Job Title

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: o FDA 21 CFR Part 820.30 (Design Controls) o ISO 13485 (Quality Management Systems) o ISO 14971 (Risk Management) o 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 commu