V& V Engineer

Company Name: WillWare Technologies
Job Title: Verification & Validation (V&V) Engineer
Location: Pune
Work Mode: On-site
Experience Required: 4 to 6 Years

Job Summary

We are looking for an experienced Verification & Validation (V&V) Engineer to lead verification and validation activities for ventilator and respiratory medical devices. The role requires strong system-level testing expertise regulatory knowledge and experience working in a highly regulated medical device environment.

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.

Required Skills:

design controlsV&V for medical devicesCPAP BiPAP