Hi ,


Hope you are doing well.

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



*Position:           *Validation Engineer (Medical Devices)

*Location:*          Round Lakes, IL

*Duration:*         6 Months+



*We require Bachelor’s or Master’s degree in Mechanical Engineer.*



*Job Description:*

• Minimum 7-9 Years of overall experience on Mechanical Engineering -
Degree in Mechanical Engineering or equivalent - B.E / B.Tech / B.S / M.E /
M.Tech / M.S

• Minimum 5+ Experience in Medical domain

•Experience in Test Method Validation (Analytical Method, Attribute Test
Method, Compendium Method, Destructive Test Method, Design of Experiment,
Gage R&R, Inspection Method, MSA, Non-Destructive Test Method and Variable
Test Method)

• Experience in functional / system testing and feasibility studies for
medical devices

• Experience in Validation and Verification Activities for Medical devices

• Hands-on approach in lab environment

• Experience in writing protocols and reports

• Experience in Developing Fixtures

• Basic understanding and experience on test setup

• Experience in mold validation process is added advantage

• Experience in Statistics (i.e. Mini Tab Analysis) / Engineering Analysis

• Supplier Documentation Review

• Good Communication, writing and documentation skills

• Support on HF Study

• Experience on Change Control Process.



*Skill Matrix:*

*Skills*

*Candidate Self Rating*

*Years of Experience*

*Basic*

*Intermediate*

*Expert*

 Experience in Medical Domain




   Test Method Validation




   Functional / system testing




   Validation and Verification Activities




   Writing protocols and reports




   Test Setup




   Developing Fixtures




   Mold Validation process




   Statistics (i.e. Mini Tab Analysis)




   HF Study




   Supplier Documentation Review




  Change Control Process













*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*

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