Verification & Validation LEAD

le & responsibilities

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

1. Extensive knowledge of Verification and Validation of medical devices to enable defining V&V strategy for the products and executing them to fulfil the regulatory and quality requirements of the product.

2. Develop verification plan for the NPI programs including, resource, budget, timelines. Execute as per plan and provide periodic status reports.

3. Hire and manage the V&V team for product programs - assign daily task schedules and monitoring while managing any unforeseen delays.

Manage traceability, Issue resolutions working closely with cross functional engineering and program team members

• 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

Preferred candidate profile

a. Bachelors or Masters Degree in Engineering with minimum 8 years of Verification and validation experience working with cross-functional teams in an industry environment

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

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

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.
• Hands on experience in Root cause analysis methodologies, Demonstrated problem-solving and leadership skills.
• Strong technical orientation for understanding multi-disciplined systems.
• Good documentation skills and ability to communicate effectively at all levels of the organization.
• Can conform to shifting priorities, demands and timelines through analytical and problem-solving capabilities. Ability to effectively prioritize and execute tasks in a high-pressure environment.
• Multi-tasker, independent, punctual and accurate with excellent organizational skills, Team oriented, collaborative, good personal relationships.
• Familiarity with requirement, defect and software management tools
• Experience designing, building, and maintaining instrumented test systems or electronic systems
• Ability to work in a high paced, dynamic environment with a variety of people