Principal Engineer Lab Testing & Admin

Role & responsibilities

1. Bachelors/master's degree in mechanical engineering or equivalent relevant technical degree.

2. 9 to 14years of relevant Experience in Systems & Component level Verification & Validation activities.

3. Deep domain knowledge in design verification and validation of medical devices.

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

5. Understanding of hardware methodologies and test best practices.

Essential Duties and Responsibilities:

1. 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.

2. Partners with R&D functionals/cross functional teams to coordinate Integration and System testing of products including automated testing.

3. Plans, builds & maintains test infrastructure and manages the budget planning for the labs.

4. Demonstrated experience in accomplishing objectives. Able to deliver on multiple projects simultaneously.

5. Develops & maintains an effective & collaborative working relationship with internal & external stake holders across all levels & diverse cultures.

6. Lead V&V activities to ensure meeting customer requirements, safety, regulatory and quality needs at a committed timeline.

7. Accountable for Corporate audits, Internal audits, ISO audits and Regulatory audits by adhering to Vantive QMS.

8. Lead and Drive to closure if there is an NC's or Findings during Audits by taking necessary actions.

9. Lead and Execute IQ,OQ and PQ for equipments & Instruments as per QMS site policies.

10. Ensure lab requirements are validated & labs are qualified for the intended use, coordinate for common Equipment usage incase of need.

11. Responsible for Qualification of Vendors & add them to approved vendors list by coordinating with sourcing team in quick turn around time.

12. Must be self-motivated & have good interpersonal skills, capable of analyzing and solving complex problems through innovative thought and experience.

13. Hands on Experience in handling Mechanical Equipments like UTM, Leak Tester, Torquer Tester and other instrument and Equipments would be added advantage.

14. Responsible for Design and Development of fixture per V&V needs by preparing drawing and working closely with external vendors.

15. Work with Cross Functional Teams Globally and ensure completion of Cross functional V&V tasks.

16. Exposure to Regulatory Standards & Manufacturing process and procedure for Medical Devices and RF welding, Solvent bonding process would be an added benefit.

17. Exposure to statistical tools like Minitab and Six sigma methodology for results analysis would be an added advantage.

18. 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.