13 Aug
|
Glauben Technologies
|
Pune
13 Aug
Glauben Technologies
Pune
Job Summary
We are looking for an experienced Verification & Validation (V&V;) Engineer with 6+ years of hands-on experience in the medical device industry. The ideal candidate will be responsible for planning, developing, executing, and documenting verification and validation activities throughout the medical device product development lifecycle.
The candidate should have solid knowledge of medical device development processes, design controls, risk management, test methodologies, and regulatory requirements, with proven experience in preparing and reviewing technical documentation.
Key Responsibilities
- Develop and execute Verification & Validation strategies, plans, protocols, and reports for medical device products.
- Define verification methods, acceptance criteria, test requirements, and traceability based on product specifications and user requirements.
- Prepare and review V&V; protocols, test cases, test procedures, test reports, and summary reports.
- Execute and coordinate design verification and validation testing for medical devices and associated systems/components.
- Establish and maintain Requirements Traceability Matrix (RTM) linking user needs, system/product requirements, design inputs, and verification/validation evidence.
- Work closely with R&D;, Systems Engineering, Quality, Regulatory, Manufacturing, and Clinical teams to ensure V&V; activities are completed as per project timelines.
- Support risk management activities in accordance with applicable medical device standards and procedures.
- Review design changes and assess their impact on existing verification and validation activities.
- Support verification of software, hardware, mechanical, electrical, and system-level requirements, as applicable to the product.
- Identify, investigate, document, and support resolution of test failures, non-conformances, and deviations.
- Ensure V&V; documentation complies with internal procedures and applicable regulatory requirements.
- Participate in d
📌 Validation and Verfication Engineer (Pune)
🏢 Glauben Technologies
📍 Pune