Job Description :
Position: R&D Engineer-NPD
Location: West Chester, PA
Duration: 12+ Months
Job Description:
Duties & Responsibilities:
Function : Design –Medical Devices
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,
Knowledge in risk management (ISO 14971),
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 10 years of experience in Medical device design, Manufacturing, Verification & Validation.
Preferred Orthopaedic implants /Bone screws/surgical instruments design.