Hi,

Hope you are doing great.

Kindly have a look below Job Description, and let me know your interest in
this opportunity.


*Let me know if needed any help from my end. You can reach me via Email:
[email protected] <[email protected]>, Ph: (609) 890 0316 *802*



*Title:               Mechanical Product Development Engineer (Medical
Devices)*

Location:         West Chester, PA

Duration:         1 year plus contract



*Skill Matrix:*



*Required skills*

*No. of years of experience*

*Last used year*

Product Development (R&D)





Medical Devices





Risk management techniques





CAPA process and root cause investigation.





FDA submission, MQMS process - ISO 13485.





DHF Audit / Remediation / any Quality engineering related activities.







*Job description:*



• 5+ years of relevant product development or R&D experience (preferably in
Medical device industry / Orthopedic)

• Degree in Mechanical Engineering or equivalent - B.E / B.Tech / B.S / M.E
/ M.Tech / M.S

• Knowledge of medical device design controls and project management.

• Demonstrated knowledge of sound design principles and practices.

• Demonstrated knowledge of risk management techniques.

• Demonstrated knowledge of CAPA process and root cause investigation.

• Familiar with working within formal design control processes, writing
test protocols and reports.

• Knowledge / experience on FDA submission, MQMS process - ISO 13485.

• Experience with designing and testing medical devices.

• Experience with CAD Tool - Pro-E, Intralink.

• Proven record of interpersonal skills to handle client, Result oriented
and self-driven.

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