Verification & Validation Specialist

4 hours ago


Pune Maharashtra India, Maharashtra NMD Placement Consultancy Full time

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.
  • 3–6 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



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