Job Description

BE in Mechanical Engineering with 7 to 10years of experience in Medical and Aerospace Domain.

Essential Duties and Responsibilities:
Contributes through demonstrated hands-on participation in Leading Engineering Change controls & Testing activities.
Exposure to GDP and GMP is must.
Hands on Experience in handling Mechanical Equipments like UTM, Leak Tester, Torquer Tester and other instrument and Equipments would be added advantage
Ability to write testing protocols independently with minimum guidance.
Hands on experience in Creo or SolidWorks is must.
Responsible for Design and Development of fixture per V&V needs by preparing drawing and working closely with external vendors.
Responsible & Accountable for project deliverables.
Lead all DHF tasks & Risk management tasks Hands on.
Work with Cross Functional Teams Globally ensure completion of Cross functional tasks.
Experience in Handling Plastic components, Design of Connectors is preferred.
Exposure to Regulatory Standards and Manufacturing process and procedure for Medical Devices.
Exposure to RF welding, Solvent bonding process would be an added benefit.
Exposure to statistical tools like Minitab and Six sigma methodology for results analysis would be an added advantage.
Ability to Plan DoE to resolve any issues to technical discussion and support and product install based.
Ability to conduct verification and validation tests to support changes as per QMS process.
Ability to do project planning for Leading the installed base tasks.
Ability to resolve to field issue - Perform NCR/CAPA.
Responsible for completion of MDR activities related to assigned families.
Responsible for 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.