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Position 3778
Manufacturing Automation Engineer

We are searching for a Senior Manufacturing Automation Engineer to join our client's Manufacturing Automation group for medical devices.

As a part of this group, you will help oversee all manufacturing processes. You will drive quality improvements while reducing labor costs through implementation of manufacturing automation.

This role will be located onsite in our client's corporate office in Elkton, MD or Ann Arbor, MI

$92K - $107K depending on skills and experience

Excellent benefits including an annual 10% performance bonus and 6% 401K match.

Minimum four-year degree in a related discipline.

Occasional travel to factories

  • Senior Mechanical, Electrical, and/or Controls engineering skills and experience with manufacturing equipment required.
  • Strong understanding of machine design.
  • Experience with equipment specification and design, build, acceptance and installation.

  • Experience within Medical Device Quality Systems (FDA 21 CFR Part 820 and ISO 13485).
  • Experience writing User Requirement Specification (URS) documentation
  • Experience with Factory Acceptance Testing (FAT)
  • Experience with Supplier Acceptance Testing (SAT)
  • Experience with Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols

  • Oversee all manufacturing processes including driving quality improvement while reducing labor costs through implementation of automation.
  • Work closely with Product Development on design for manufacturability.
  • Work closely with Operations to ensure a smooth transition into production.

Manufacturing Automation Engineer | Regulated Environment | Medical Device | FDA 21 CFR Part 820 | ISO 13485 | USer Requirement Specification | URS | Factory Acceptance Testing | FAT | Supplier Acceptance Testing | SAT | Installation Qualification | IQ | Operational Qualification | OQ | Performance Qualification | PQ | Machine Design | 3778

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