Design Quality Engineer

WI

Job ID: 115727 Industry: Quality



 Design Quality Engineer

 

Environment:

Our client is a large plastics and injection molding contract medical device manufacturer. One of their current clients provides an ocular implantable device with drug delivery capability. The client is currently in need of a consultant to come in and help with Design Quality Engineering aspects of the development of this device.

Principle Duties and Responsibilities:

The client is currently developing an ocular implantable drug-delivery (combination) device. The consultant will be from a Medical Device and/or Pharmaceutical background, and will have worked with combination devices in the past. The consultant will be from responsible for Design Assurance activities such as writing and review of Design History Files, DFMEA’s. A good portion of the role will be concerned with Gap Analysis and Document Review but there will also be hands-on technical development responsibilities. It would be a plus if this consultant has worked with drug-release devices, specifically related to the eye.

Required:
  • 5-7 years Medical Device/Pharmaceutical
  • 5-7 years Design Quality Engineering
  • DHF
  • DFMEA
  • Documentation Writing and Review

 


Plus:
  • Drug-Release Devices
  • Ocular Devices

 

 

 

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