Medical Device Validation Engineer

Denver, CO

Industry: Medical Device Job Number: 133358



                                    Medical Device Validation Engineer 

Environment: 
Our client is a large medical device manufacturer. They are manufacturing a number of class II and III medical devices. 

Principle Duties and Responsibilities: 
The consultant will be a process validation consultant with medical device experience. This individual will be reviewing and re-validating nail products from their flagship product line. Some of the standards have changed so they need to re-validate according to updated requirements. The consultant must be comfortable digging through the client’ s protocols and determining where issues are how to remediate those issues. They will be performing design experiments, analyzing data, and reviewing protocols to ensure they are complete and accurate. They will have a team writing the actual protocols but experience with managing validation activities for an entire family line (IQ, OQ, PQ) would be a huge plus. They use CNC machining so experience with machining operations is desirable. They are looking for a manufacturing/quality background rather than a design background. CSV experience is also a plus. 

Required: 
Validation 
Medical Device 
Manufacturing 
Machining Operations 


Desired: 
CSV
Windchill 

Job Type: Contract 

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