Windchill Document Change Control Engineer

Michigan, Kalamazoo-Battle Creek

Posted: 07/18/2019 Industry: Engineering Job Number: 13289



Our client, a Global Leader in the Medical Device Industry has an immediate opening for a Windchill Document Change Control Engineer for a 9 month + Contract.   Our client offers results-driven people a place where they can make a difference every day!   You will also have the opportunity to work with other like-minded, self-directed and detail oriented Top Talents in an extremely collaborative and professional environment.  



Position Description (Principle Duties and Responsibilities)




Responsible for initiating, validating, and verifying the integration of acquired medical devices DHFs (design history files) into the client s QMS (quality management system).   Due to market driven requirements, there will be changes to the product during this integration.   Changes will at least include modify labeling, IFUs, and part markings.   May be responsible for other DHF document drafts and management of RoHS or other restricted substances in product design.   0-1 year experience in medical device or similar field desired.

This role will be supporting our client and a project to integrate acquired medical device products into our clients.

  • Responsible for ensuring the complete DHF and related PLM change requests are implemented in an organized and structured manner.

  • Responsible for owning change requests to update labeling for compliance to applicable market requirements.

  • Will support change notices, change tasks for updating labels, IFUs, and product markings.

  • Develop DHF tangibles for review by the team.

  • Coordinate with SMEs and approvers.



Requirements:



  • Experienced with Windchill

  • 2 year scientific or technical degree required,   Bachelor s in engineering degree desired.

  • Candidates should have experience running cross-functional projects and technical writing

  • Top 3 Must-Haves:

o         1. Experience with Windchill

o         2. Attention to detail

o         3. Good communication

  • Top 3 Nice-To-Haves:

o         1. Ability to work independently with little direction

o         2. Medical device experience

o         3. Project management


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