Education Qualification:
1. Bachelor's degree in mechanical engineering, or equivalent relevant technical degree.
2. 5 to 8 years of Experience in Systems & Component level Verification & Validation activities, Risk management, PDLM.
3. Relevant technical testing/reliability experience in Plastic/Connectors/Products/electro mechanical.
4. Understanding of hardware methodologies and test best practices.
Essential Duties and Responsibilities:
1. Lead and Execute SPO activities like Label content verification, Design verifications, MDR & Change Control activities for PD and HD Disposables.
2. Accountable for Leading product design verification and validation activities across multiple sites across the product development lifecycle.
3. Lead and Execute change through creative solutions adapting to the new product test methods and technologies and driving test automation to enhance the assured quality and productivity in test deliverables.
4. Lead V&V activities to ensure meeting customer requirements, safety, regulatory and quality needs at a committed timeline.
5. Authorize in preparing test protocols & FR's and also conduct FDR's & DIR's by taking accountability and ownership with routing, review signoff and releases and driving to the closure.
6. Adheres to client's Quality Management system and Represents in Corporate audits, Internal audits, ISO audits and Regulatory audits.
7. Lead and Execute IQ, OQ and PQ for equipments & Instruments as per QMS site policies.
8. Hands on Experience in handling Mechanical Equipments like UTM, Leak Tester, Torquer Tester and other instrument and Equipments would be added advantage.
9. Responsible for Design and Development of fixture per V&V needs by preparing drawing and working closely with external vendors.
10. Experience in medical device product development, design verification/validation, system integration, risk management, reliability engineering, process validation and Quality systems.
11. Ability to Plan & run DOE to resolve any issues to technical discussion and support.
12. Work with Cross Functional Teams Globally ensure completion of Cross functional tasks.
13. Exposure to Regulatory Standards and Manufacturing process and procedure for Medical Devices and RF welding, Solvent bonding process would be an added benefit.
14. Exposure to statistical tools like Minitab and Six sigma methodology for results analysis would be an added advantage.
15. Responsible for Leading executing all assigned test with minimal dependency on owners by considering testing timelines, providing frequent updating of test results to owners, and ownership in preparing final report by routing, review signoff and releases.
