Senior Process Engineer

Sterling Engineering; Utah; On-site; USD 90,000 - 130,000; Full time

Job summary

Sterling Engineering seeks a Senior Process Engineer to lead manufacturing improvements, process validation, and new product introductions in a medical device setting.

You will drive Lean initiatives, perform DOE/SPC analyses, oversee IQ/OQ/PQ, and mentor technicians while partnering with Quality and Operations on CAPAs and transfers.

Qualifications

• Bachelor’s degree in Engineering.
• 5+ years of medical device manufacturing experience.
• Experience with IQ/OQ/PQ, ISO 13485, FDA 21 CFR Part 820.
• Strong knowledge of DOE, SPC, PFMEA, and Lean Manufacturing.
• Minitab experience.

Responsibilities

• Lead process improvement and Lean initiatives to improve quality, efficiency, and throughput.
• Develop and validate manufacturing processes (IQ/OQ/PQ).
• Conduct DOE, SPC, Gage R&R, and root cause analysis.
• Support new product launches and process transfers.
• Partner with Quality and Operations to drive CAPAs and continuous improvement.
• Mentor technicians and engineers while leading technical projects from concept to implementation.

Skills

Lean manufacturing

DOE

SPC

PFMEA

Root cause analysis

Process validation

Education

Bachelor’s degree in Engineering

Tools

Minitab

SOLIDWORKS

Job description

Are you passionate about continuous improvement, Lean manufacturing, and process optimization? We're partnering with an innovative medical device manufacturer looking for a Senior Process Engineer to lead manufacturing improvements, process validation, and new product introductions.

What You'll Do

• Lead process improvement and Lean initiatives to improve quality, efficiency, and throughput.
• Develop and validate manufacturing processes (IQ/OQ/PQ).
• Conduct DOE, SPC, Gage R&R, and root cause analysis.
• Support new product launches and process transfers.
• Partner with Quality and Operations to drive CAPAs and continuous improvement.
• Mentor technicians and engineers while leading technical projects from concept to implementation.

What You Bring

• Bachelor's degree in Engineering
• 5+ years of medical device manufacturing experience
• Experience with IQ/OQ/PQ, ISO 13485, FDA 21 CFR Part 820
• Strong knowledge of DOE, SPC, PFMEA, and Lean Manufacturing
• Minitab experience (SOLIDWORKS is a plus)