Design Control/Validation Engineer

Colorado Springs, CO

Job ID: 132104 Industry: Medical Device

Design Control/Validation Engineer

 Background:

Our client is a large medical device company that makes and manufactures a variety of class II and III medical devices. This person will be helping to finish up a 2 year remediation effort in response to an FDA warning letter. They are seeking an engineer strong in Design Validation and Design control, to handle some of that type of work that will take them into the closing phases of the project.

Responsibilities:

This consultant should have experience of 3-5 years in the Medical Device industry working as an ME/Design Validation Engineer. They will be tasked with assisting with validation documentation for MVPs, CAPA, Lot Monitoring, etc. The primary validation that will be dealt with is centered around Design Validation and Design Control.  They will help implement strategies and and justify gaps around design control. This person must be hands on, a great communicator, and willing to be thrown into different situations on the fly. The team is looking for someone who can be flexible and quickly learn their protocols and procedures to start adding value early on.

Required:
  • Medical Device Experience  3-5 years
  • Process Validaiton
  • IQ OQ PQ
  • Master Validation Plans
  • Risk Assessment Documentation 

Plus:
  • Design Control

Job Type: Contract

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