Education Qualification:

Bachelor’s/master’s degree in mechanical engineering, or equivalent relevant technical degree.  

7 to 12years of relevant Experience in Systems & Component level Verification & Validation activities.

Relevant technical testing/reliability experience in Plastic/Connectors/Products/electro-mechanical. 

Understanding of hardware methodologies and test best practices. 

Essential Duties and Responsibilities:

Own change management activities for development and sustaining projects, including technical coordination, design control documentation, change implementation, data management, lifecycle verification, and cross-functional alignment.

Plan, design, and execute R&D studies for disposables, including support for manufacturing readiness, verification and validation, and product specification updates.

Active Supports to PDO in design control activities, documentation (DHF), change implementation, data management, LCV and coordination across functions.

Lead product design verification and validation activities across multiple sites throughout the product development lifecycle.

Drive improvements in product test methods, technologies, and test automation to enhance quality, efficiency, and productivity in test deliverables.

Lead verification and validation activities to ensure customer, safety, regulatory, and quality requirements are met within committed timelines.

Lead SPO activities for PD Disposables, including label content verification, design verification, MDR support, and change control execution.

Prepare test protocols, final reports, FDRs, and DIRs, ensuring proper routing, review, sign-off, release, and closure.

Adhere to the Vantive Quality Management System and represent the function during corporate, internal, ISO, and regulatory audits.

Lead and executeIQ, OQ, and PQ activities for equipment and instruments in accordance with QMS site policies.

Hands-on experience with mechanical equipment such as UTM, leak testers, torque testers, and other relevant instruments would be an added advantage.

Design and develop fixtures to support V&V needs by preparing drawings and working closely with external vendors.

Experience in medical device product development, design verification and validation, system integration, risk management, reliability engineering, process validation, and quality systems.

Plan and execute DOE activities to support technical investigations, issue resolution, and data-driven decision-making.

Collaborate with global cross-functional teams to ensure timely completion of assigned tasks and project deliverables.

Exposure to regulatory standards, medical device manufacturing processes, and procedures, including RF welding and solvent bonding, would be an added advantage.

Exposure to statistical tools such as Minitab and Six Sigma methodology for results analysis would be an added advantage.

Lead assigned testing activities with minimal dependency on owners by managing timelines, providing regular test result updates, and preparing final reports through routing, review, sign-off, release, and closure.