Title: Product development engineer
Location: West Chester, PA
JD:
- Responsible for End-to-End Product design & development,
- Developing conceptual design of new products entailing drawings & specification study, quotation enquiry & finalization, FOT&FAI and supporting PPAP documentations
- Good experience in Usability engineering, DFMEA, DFM, GD&T and Tol. stack up analysis.
- Ability to work in a regulated work environment and previous experience with ISO 13485 standard and FDA and MDD regulations,
- Experience on PLMs (Windchill and Agile).
- Experience in developing prototype &Engineering build samples with Manufacture &Product Testing.
- Good experience in writing test protocol& Reports for Mechanical and Usability lab testing.
- Experience in clinical settings such as in vivo labs, and hospital OT room.
- Good working experience in CREO
- Knowledge in Metal and Plastic Manufacturing process & Techniques.
- Ability to take up ownership and work independently,
- Should have resource management skills to hold discussions with the stakeholders for sharing feedback and work with them for completion,
- Design review & Technical guidance to the team.
Qualification:
- Mechanical Engineer with minimum 5 years of experience in Medical device design, Manufacturing, Verification & Validation.
- Preferred Orthopaedic implants /Bone screws/surgical instruments design.
