Sr. Process Engineer – Injection Molding | Medical Device Manufacturing
? Salt Lake City
? Up to $150,000
A large and growing medical device manufacturer is seeking a Sr. Process Engineer with strong injection molding experience to support high-volume, highly regulated manufacturing operations. This role will focus on optimizing thermoplastic injection molding processes, driving continuous improvement, and supporting validation activities within an ISO 13485 and FDA-regulated environment.
Responsibilities
- Optimize and troubleshoot injection molding processes for medical device manufacturing
- Lead process validations including IQ/OQ/PQ
- Conduct DOE studies, SPC analysis, root cause investigations, and process capability improvements
- Support tooling, automation, and new product introductions
- Drive Lean Manufacturing and continuous improvement initiatives
- Partner with Quality and Operations on CAPA, NCR, and change control activities
Qualifications
- Bachelor’s degree in Engineering or related field
- 5+ years of process engineering experience in medical device manufacturing
- Strong background in thermoplastic injection molding
- Experience working within ISO 13485 and FDA-regulated environments
- Hands-on experience with IQ/OQ/PQ, DOE, SPC, PFMEA, and Minitab
- Strong troubleshooting and problem-solving skills
This is an excellent opportunity to join a stable, expanding organization offering strong career growth, advanced manufacturing technologies, and a collaborative engineering environment.
Qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or genetic information. #inauto