Hi


Hope you are doing well.

Kindly have a look below job description and do let me know your interest
in this opportunity.



*Title:                          Mechanical Product Development Engineer -
Medical Devices*

*Location:*                   West Chester, PA

Duration:                    1 year plus contract

*Experience Level:*   3-10 years, junior to mid-level candidates.



*Skill Matrix:*



*Required skills*

*No. of years of experience*

*Last used year*

Product development or R&D experience in Medical devices industry





Medical devices industry experience.





Medical device design controls





Risk management techniques.





CAPA process and root cause investigation.





Writing test protocols and reports.





Knowledge on MQMS process - ISO 13485







*Required Skills:*



§  Minimum 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.

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



*Let me know if needed any help from my end. You can reach me via Email:
je...@gtssminds.com <je...@gtssminds.com>, Ph: (609) 890 0316 *802*

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