Medical Device Manufacturing Engineer

Denver, CO

Industry: Medical Device Job Number: 147030
   
Medical Device  Engineer (Labeling Project)

 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 provide a wide range of engineering support for a project involving a new labeling system across multiple sites, as well as the validation of that system.

Responsibilities:

This person will be supporting a year long effort regarding a new labeling system called enLabel. There are technical individuals in place to perform software validations, but this person will be supporting the project in other areas. A day to day will involve Work Instruction updates, processing Engineering Change Requests (ECR' s), Engineering Change Orders (ECO' s), Change Controls, etc. They will also assist with updating several sites documentation in relation to the changes to their labeling system. Some bar code verification and rebranding will be involved also.  There may also  be some work involved validation activity, from an execution standpoint (IQ OQ PQ).

A successful candidate does not need to have experience with labeling, but rather be a well-versed engineer who can hit the ground running and operate with little direction from management while work cross-functionally with other engineers. The team needs a go-getter who can come to problem resolution on their own and seek out the resources needed to push the project forward. 

Required:
  • Medical Device Experience 5-10 years
  • Engineering background- Manufacturing, Mechanical, Quality, Electrical, etc.

Plus:
  • Labeling enhancements
  • Validation (IQ OQ PQ- Software/Process)

Job Type: Contract 

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