Michigan, Kalamazoo-Battle Creek
Our client, a Global Medical Device Manufacture has an immediate opening for a Manufacturing Engineer for a 12 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)
The purpose of this role is to support our client with their European Medical Device Review / EUMDR project and to make Improvements and updates to operations / manufacturing instructions, routes and inspection criteria. In this role an assessment of existing tech files to identify gaps and remediate accordingly will be conducted all in an effort to be compliant with updated EUMDR requirements
Top MUST-HAVE qualifications
1. Understanding of manufacturing operations within a regulated environment
2. Prioritize and execute independently once on board.
3. Experience with in process controls, validation, control plans, DHR creation etc.
4. Minimum Bachelor s degree in Engineering
Top 3 desired qualifications:
1. Medical device experience
2. Change control experience
3. Solid non-expert regulatory knowledge FDA, ISO 13485, EUMDR
Our client has planned 2-3 weeks of ramp up time. Expectations after training is completed:
Understand the project scope and status.
Work with existing contractor(s) to get up to speed on systems and processes.
Gain access to appropriate systems.
Meet appropriate players.
Begin completion of actions per project plan.
Escalate concerns, needs or roadblocks.