Job Description
Location:: philadelphia, USA
Visa Status:: Any work visa (Visa sponsorship available)
Salary::35/hr.
Duration::
Job Description:
Duties & Responsibilities:
§
Responsible for End to End Product design & development,
§
Developing the conceptual design of new products entailing drawings &
specification study, quotation inquiry & finalization, FOT&FAI and
supporting PPAP documentation
§ 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 processes & 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 a minimum of 10 years of experience in Medical
device design, Manufacturing, Verification & Validation.
§ Preferred
Orthopedic Implants /Bone screws/surgical instruments design.
Qualification::
.jpg)
