Change Control Engineer
Michigan, Kalamazoo-Battle Creek
Our client, a Global Medical Device Manufacture has an immediate opening for a Change Control Engineer for a 6 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.
Partners with design engineers to initiate engineering change orders in OnePLM.
This position will become a subject matter expert in the change management system and provide a support function to the group.
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.
Experienced with Windchill / ProE
2 year scientific or technical degree required, engineering degree desired.
Candidates should have experience running cross-functional projects and technical writing
Top 3 Must-Haves: 1. Experience with Windchill 2. Attention to detail 3. Good communication
Top 3 Nice-To-Haves: 1. Ability to work independently with little direction 2. Medical device experience 3. Project management