Verification and Validation

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.

·        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.