Job Title : Verification & Validation Specialist

Reporting to: Project Manager/Systems Engineering Lead

Location: Bangalore/Pune

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)

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

Verification Validation Engineer