Engineer Sr, Manufacturing

Hello,

My name is Corey, and I am a Recruiter with The Fountain Group. We are a national staffing firm and are currently seeking a Senior Manufacturing Engineer for a prominent client of ours. This position is located in Plymouth, MN. Details of the position are as follows:

(Cannot support visa sponsorhip at this time)

Job Description:

• Pay is up to $53/hr.
• 11-month assignment with strong possibility of extension based on performance and budget.
• Employee will need to work with both ABT manufacturing and supplier to execute transfer activities including planning, equipment moves, supply chain component transfer, process knowledge transfer, validation support, and continuous improvement activities.
• This position will design and develop manufacturing processes, tooling, and fixtures to meet daily production schedules while enhancing productivity and product quality.
• Provide technical mentorship to engineers and technicians Conduct Process FMEAs and Process Validations Improve product quality, labor efficiency, and throughput using Lean manufacturing concepts Coordinate the design, procurement, build and debug of tooling.

Qualifications:

• Degree with 4+ years' in Manufacturing Support, medical device highly desired -
• Experience in contract manufacturing transfers: Familiarity with end-to-end outsourcing processes, including planning and execution of tech transfer.
• Strong understanding of manufacturing processes: Especially related to assembly, testing, and packaging of medical devices.
• Process validation expertise: IQ/OQ/PQ protocols, equipment qualification, and statistical techniques (e.g., Gage R&R, DOE).
• Understanding of FDA QSR (21 CFR Part 820) and ISO 13485 compliance requirements.
• Experience with DHF, DMR, and risk documentation (FMEA, pFMEA).

If you are interested in hearing more about the position, please respond to this post with your resume attached.

Please forward this email to any friends or colleagues as we do offer a Referral Bonus for any candidate who is hired and still gainfully employed after 30 days.