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
All qualified applicants will receive consideration without regard to race, age, color, sex (including pregnancy), religion, national origin, disability, sexual orientation, gender identity, marital status, military status, genetic information, or any other status protected by applicable laws or regulations.
GPAC (Growing People and Companies) is an award-winning search firm specializing in placing quality professionals within multiple industries across the United States since 1990. We are extremely competitive, client-focused and realize that our value is in our ability to deliver the right solutions at the right time.
