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.
36 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-Pune

Notice Period- upto 45 days

Verification & Validation Specialist