Verification And Validation Engineer

PURPOSE OF THE POSITION:

Responsible for driving verification and validation activities for medical device NPIs including planning, resource management, execution.

MAJOR 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.
• Define & Execute the Usability & Ergonomic Verification Test protocols.
• Develop and execute reliability and integration tests for prototypes and products.
• 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 analysing 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
• Participation in project meetings, project reviews, and specification reviews.
• Identify and report any quality or compliance concerns and take immediate corrective action as required.

REQUIREMENT PROFILE: (Qualification, No of yrs exp)

a. Bachelors or Master’s Degree in Engineering with minimum 4 years of Verification and validation experience working with cross-functional teams in an industry environment

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

Proven Verification & Validation experience in medical device industry with a strong emphasis on problem solving, along with written and verbal skills