Process Engineer (Medical Devices) – Validation & Lean

Energy Jobline ZR; Providence (RI); On-site; USD 75,000 - 110,000; Full time

Benefits offered by this job

401(k) match program

Dental, health, and vision insurance

Paid time off

Job summary

Energy Jobline ZR is seeking a Process Engineer in Providence, RI to work closely with Operations, Quality, and Design teams to optimize product quality and ensure regulatory compliance. The role focuses on validating processes, establishing CPPs, and driving continuous improvement from development through full-scale production.

You will lead DOE studies, apply Six Sigma and Lean principles, and coordinate with cross-functional teams to implement validated processes across the Americas.

Qualifications

• Bachelor's degree in engineering required; advanced degrees or certs are a plus.
• 3–5+ years in process/manufacturing/operations engineering within a regulated industry.
• Hands-on process validation (IQ/OQ/PQ) experience is required.
• Strong knowledge of ISO 13485 and FDA 21 CFR Part 820; audit SME.

Responsibilities

• Develop and execute IQ/OQ/PQ validation protocols for thermoforming and sealing processes.
• Define CPPs, PAR, NOR through development studies and DOE.
• Lead statistical analysis of validation data aiming for Cpk ≥ 1.33.
• Own Process Design, Qualification, and Continued Process Verification lifecycle.
• Define and optimize process parameters including temp, vacuum/pressure, and cycle times.
• Lead IQ/OQ equipment qualification for supporting equipment.
• Ensure compliance with ISO 13485, ISO 11607-1/2, and FDA 21 CFR Part 820.
• Utilize Minitab or similar for DOE, capability, SPC, Gage R&R, and data analytics.
• Lead PFMEA, CAPA, and root-cause investigations (5-Why, Fishbone, DMAIC).
• Collaborate across Operations, Quality, Supply Chain, and Design to align improvements.
• Train production teams on validated processes and in-process monitoring.
• Apply Lean and Six Sigma to reduce waste and improve efficiency.

Skills

DOE

Six Sigma

Problem solving

Leadership

Education

Bachelor's degree in Mechanical/Manufacturing/Industrial/Chemical Engineering

Tools

Minitab

Job description

Energy Jobline ZR is seeking a Process Engineer in Providence, RI to work closely with Operations, Quality, and Design teams to optimize product quality and ensure regulatory compliance. The role focuses on validating processes, establishing CPPs, and driving continuous improvement from development through full-scale production.

You will lead DOE studies, apply Six Sigma and Lean principles, and coordinate with cross-functional teams to implement validated processes across the Americas.