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Senior Medical Device Manufacturing Engineer

Expired Job

Alku Denver , CO 80201

Posted 4 months ago

Senior Medical Device Manufacturing Engineer

Environment:

Our client is a large medical device manufacturer. They develop and manufacture a number of class 3 medical devices- primarily catheters. They are in need of a Senior Manufacturing Engineer with a Medical Device take on sustaining activity across multiple projects, while full time personnel focus on a new Document Control PLM system upgrade from Agile to Windchill.

Responsibilities:
This person will be responsible for handling several Manufacturing Engineering activities associated with a variety of ongoing projects within the company. The support is needed over the next 12-18 months while some FTEs are assigned to an Agile to Windchill PLM upgrade/transformation. This person should come from a background of 7-12 years in the Medical Device industry, working as a Manufacturing Engineer. The role is focused on sustaining activity, and may include tasks like the following:

  • Manufacturing Engineering support, working in a hands on manner with manufacturing/technicians/on the floor etc.

  • Validation and validation documentation (Process, TMV, etc.)

  • Working within CAPAs from an engineering perspective

  • IQ OQ PQ, PFMEA & DFMEA, Failure Analysis, etc.

As well as other manufacturing based activity.

This person will be expected to be able to own projects independently as well as work cross-functionally with other groups. The role is for a self-starter, someone who is excellent in communicating progress to management, maintain proper documentation methods, etc.

Required:

Medical Device

Medical Device Manufacturing experience

Process Validation IQ OQ PQ

Plus:
Class 3 Medical Devices

Highly motivated and effective communicator

Job Type: Contract


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Senior Medical Device Manufacturing Engineer

Expired Job

Alku