Verification and Validation
ConfidentialPune, India3 days ago
Job descriptionMaintain 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. MTech / ME / BE / BTech in Biomedical, Electrical, Mechanical, or Systems Engineering. 6–12 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.
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 :
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)
Education & Skills preferred :
Skills Required
Iso 14971, Iso 13485, iec 60601 , Performance Testing, Hp Alm, Test Methodologies, Root Cause Analysis
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Verification • Pune, India
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