Conduct testing in the lab understand flow of events and needby timelines coordinate and communicate with all parties and mitigate any problems that arise.
Perform test method and fixture updates including test method validation and equipment IQs etc.
Responsible for Initiating Build Requests with the manufacturing team.
Knowledge about tensile strength testing fatigue testing pressure testing torque testing etc.
Knowledge about various lab equipments like Instron tester torque tester etc.
Manage Design Freeze and Design Verification testing and data analysis using Minitab.
Manage testing based on the workload and uploading relevant documents (test results checklists etc. and Images in agile.
Troubleshoot testing issues and provide solutions to ensure continuity of verification testing.
Support in designing the product and test fixture.
3D Modeling & detailing of test fixtures using SolidWorks.
Knowledge of Product Lifecycle Management (PLM) and exposure to PLM tools like Agile Windchill Team center etc.
Transfer of DHF deliverables to the new templates.
Facilitate RCA and CAPA.
Manage relationships with external vendors and suppliers for ordering components.
Collaborate with crossfunctional teams for review and approval of the deliverables and associate change orders in Agile.
Communicate effectively with key stakeholders to ensure alignment and understanding of scope of activity and associated artifacts.
Must know about medical device compliances regulations & standards (ISO 13485 ISO 14971.
Continuously evaluate and improve the processes and procedures to increase efficiency and reduce cycle time.
Proficiency in requirement engineering risk analysis and V&V activities.
Participate in risk assessments and ensure product designs meet safety regulatory and quality standards.
Contribute to additional tasks such as design support or support any activity required in the R & D department.
Strong communication skills provide guidance and technical support to crossfunctional support teams.
Prepare regular updates and presentations for senior management.
Educational Qualification:
B/E. Tech in Mechanical Engineering Production Engineering or similar associated stream.
Engineer having experience of 10 years with exposure to Medical Equipment R&D process.
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