Job Description :
Position: Mechanical Engineer/Manufacturing Engineer
Location: West Chester, PA
Duration: 12+ Months

Job Description:
Skills:
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 in developing prototype &Engineering build samples with Manufacture &Product Testing.
Good experience in writing test protocol& Reports for Mechanical and Usability lab testing.
Knowledge in Metal and Plastic Manufacturing process & Techniques
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.

Technical Skill:
A Bachelor’s degree in Mechanical or Manufacturing discipline, with a minimum of 10 years of experience in the medical device industry or healthcare field is required
Advanced technical writing skills is required, with demonstrated experience in writing PMCF plans / reports strongly preferred
Strong project management skills required, with demonstrable track record of success managing multiple projects simultaneously with minimal supervision.
Should have resource management skills to hold discussions with the stakeholders for sharing feedback and work with them for completion.
Previous experience developing strategies to generate clinical evidence is strongly preferred.
Must have ability to develop and maintain business partnerships at all levels of the organization.
Expertise / proven record of working with onsite-offshore business model on mechanical engineering projects.
Adheres and comply to work instructions, Standard Operating Procedures.