Verification And Validation Engineer

Transasia Bio Medicals; Bengaluru; On-site; INR 1,500,000 - 2,000,000; Full time

Job summary

Transasia Bio Medicals is seeking a Verification & Validation specialist to support NPIs in the medical device domain. You will plan, execute, document, and report V&V activities to meet regulatory and quality requirements, coordinating with cross-functional teams.

Your role involves maintaining V&V infrastructure, creating detailed plans and reports, and ensuring traceability to risk management and design controls. Strong problem-solving and communication skills are essential.

Qualifications

• Bachelor's or Master's in Engineering with relevant V&V experience.
• Minimum 3 years of Verification and Validation experience in medical devices.
• Proven V&V experience with strong problem-solving and communication skills.

Responsibilities

• Review specifications and design docs to provide feedback for V&V activities.
• Own and maintain V&V infrastructure (SOPs, forms, tools, jigs, simulators, phantoms).
• Create V&V plans, tests, and reports with traceability to Risk Analysis and Design Control documentation.
• Develop verification techniques, test setups, equipment, and environments for system tests.
• Coordinate test activities and report progress; escalate delays as needed.
• Lead Usability & Ergonomic Verification Test protocols and implementation.
• Develop reliability and integration tests for prototypes and products.
• Plan manufacturing process validation activities for NPI projects (IQ/OQ/PQ).
• Maintain DHF & DMR chapters and contribute to regulatory compliance.

Skills

Verification & Validation

Medical devices

Cross-functional collaboration

Root cause analysis

Test planning

Documentation

Education

Bachelor's or Master's in Engineering

Job description

PURPOSE OF THE POSITION

Responsible for supporting verification and validation activities for medical device NPIs including test planning, execution, documentation, and reporting.

KEY RESULT AREAS

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. Support V&V activities for product programs, execute assigned test activities, and provide timely updates on progress while escalating any unforeseen delays.
4. Manage traceability, issue resolutions working closely with cross-functional engineering and program team members.

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 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.
• Participation in project meetings, project reviews, and specification reviews.
• Identify and report any quality or compliance concerns and take immediate corrective action as required.
• In addition to the above, you may be given additional responsibilities as per business requirements and your JD can be altered at the discretion of your superiors.

REQUIREMENT PROFILE (Qualification & Experience)

a. Bachelor's or Master's Degree in Engineering with minimum 3 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 activities for NPI projects in the medical devices industry.

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

COMPETENCIES (Knowledge, Skills & Attitudes Required to Perform the Job)

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 with demonstrated problem-solving skills and ability to work effectively in a team environment.