V&V Lead

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We are looking for a V&V Lead to drive verification and validation activities for medical device NPIs including planning, resource management, execution.

▪️ Job Description:

Responsible for driving verification and validation activities for medical devices.

▪️ Responsibilities

🔹 Review specifications and technical design documents to provide timely and meaningful feedback for Engineering Verification & Validation activities.

🔹 Own & Maintain the Verification, Validation & Process Validation infrastructure (SOP, Forms, SW tools, Jigs, Simulators, and Phantoms).

🔹 Create detailed, comprehensive and well-structured V&V Plan, test protocols and reports, with traceability with Risk Analysis Matrix & Design Control documentation.

🔹 Create Verification and Validation Procedures, execute tests, and document Results.

🔹 Develop, implement and document verification techniques, test setups, equipment and environment required for System test execution.

🔹 Execution of Verification and Validation plans, including coordinating efforts of test personnel inside and outside the Design Verification and Validation group.

🔹Develop manufacturing process validation activities for NPI projects (IQ\OQ\PQ, Validation Plans, Sample size, Testing forms and Documentation).

🔹 Maintain relevant chapters of DHF & DMR.

🔹 Develop and implement of methodologies for collecting and analyzing failure data and determining root cause of failures (FTA, investigation, SPR, etc.,).

🔹 Coordinating failure analysis with other disciplines as necessary to lead to determination of root cause and close design defects.

🔹 Ensure testing abides to Engineering Quality Procedures (QMS Quality Management System), Phased Review Discipline and regulatory needs of the applicable markets.

▪️ Qualifications

🔹 Bachelor’s or Master’s Degree in Engineering with minimum 8 years of 🔹 Verification and validation experience working with cross-functional teams in an industry environment.

🔹 Minimum 3 years of experience in leading verification and validation of NPI in medical devices industry.

▪️ Technical Qualifications:

🔹 Experience in Verification and Validation, including test methodologies development at system-level for medical products that include Hardware and Software.

🔹 Strong knowledge of testing methodologies and processes, including manual, automated, standards and compliance testing.

🔹 Knowledge and experience with Medical Device Quality Systems, ISO 13485, FDA.

🔹 Knowledge and experience with environment, safety, bio-compatibility, sterility and essential performance tests (IEC 60601, EN 61508, ISO 10993-5, ISO 11135, etc.).

🔹 Demonstrated skills for planning and coordinating verification and validation activities for NPI from design to Manufacturing transfer.

Share your resume to :j.treasa@transasia.co.in