V& V Engineer

Develop, maintain, and execute Verification & Validation (V&V) strategies, plans, and protocols for ventilator systems in compliance with regulatory and quality requirements.

Define and implement test methodologies for:

• System-level verification and validation

• Subsystem-level testing (hardware, software, and mechanical)

• Component-level verification

Lead execution of functional, safety, performance, and reliability testing across all system layers.

Analyze test results, identify deviations or non-conformances, and drive resolution through root cause analysis (RCA) and corrective and preventive actions (CAPA).

Provide V&V input and support during design transfer, manufacturing readiness, and production release reviews.

Ensure complete documentation of test plans, protocols, reports, 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 and ISO 80601 standards for medical electrical and respiratory devices

Maintain audit-ready documentation including test protocols, test reports, requirements traceability matrices (RTM), and defect logs.

Support regulatory submissions by providing V&V documentation, test evidence, and technical justifications to regulatory bodies.

Collaborate closely with systems, software, hardware, mechanical, manufacturing, and quality teams to ensure comprehensive test coverage and design testability.

Participate in design reviews, risk management activities, change control boards (CCB), and failure investigations.

Utilize V&V and requirements management tools such as IBM DOORS and lifecycle/test management tools like HP ALM.

Strong expertise in medical device Verification & Validation.

In-depth knowledge of FDA, ISO, and IEC regulatory standards.

Experience in system-level testing of safety-critical devices.

Strong understanding of risk management and design controls.

Proficiency in requirements and test management tools (IBM DOORS, HP ALM).

Excellent analytical, documentation, and communication skills.