Looking for Process Engineer

We're looking for a Process Engineer to own and improve our injection molding and secondary manufacturing processes in a regulated medical device environment. You'll make sure our processes are reliable, compliant, and produce consistent quality - and you'll be the go-to technical expert for the production floor.

What you'll do

• Own the manufacturing processes for your assigned lines - set the critical parameters, keep them in control, and troubleshoot when things drift.
• Use SPC and capability data (Cp/Cpk) to catch problems early and drive them out.
• Run process validations (IQ/OQ/PQ) and keep documentation current - process flows, pFMEAs, control plans, work instructions, validation reports.
• Work with Quality on nonconformances, deviations, CAPAs, and complaints, and represent manufacturing in audits.
• Support new product launches - join design reviews, flag manufacturability issues early, and build out the validation plan.
• Lead continuous improvement work (scrap, yield, cycle time, downtime) using Lean/Six Sigma tools like DMAIC and 8D.
• Train operators and techs, and mentor junior engineers.

Requirements

• Bachelor's in Mechanical, Plastics, Manufacturing, or Industrial Engineering (or similar).
• 3–7 years in manufacturing/process engineering.
• Injection molding experience in a regulated environment - medical device experience is a strong plus.
• Solid grounding in SPC, process validation, pFMEAs, control plans, and root-cause problem solving.
• Familiarity with ISO 13485 and FDA QSR preferred; scientific molding knowledge a plus.
• Comfortable spending real time on the shop floor, juggling multiple priorities.

To be considered, please apply with a resume. If you have any other questions you can reach out to Shane Burch at (904) 420-6296 or shane.burch@gogpac.com