V& V Engineer

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Job Summary

Roles & Responsibilities

• 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.

  Required Skills

• 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.