Job Description
Roles and Responsibilities:
- Prepare test protocols and completion reports.
- Conduct testing in the lab, understand flow of events and need-by 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 equipment's 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, Wind-chill, 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 cross-functional 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 cross-functional 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.