Process Engineer
On-site · Providence, Rhode Island, United States
Job Summary
Process Engineer sought to develop and validate manufacturing processes for medical device components in Providence, RI. Responsibilities include leading IQ/OQ/PQ validations for thermoforming and sealing per ISO 11607-2 and FDA guidance; defining CPPs, PARs, and NORs; performing DOE and capability analyses targeting Cpk ≥ 1.33; managing the full validation lifecycle (Process Design, Process Qualification, Continued Process Verification); leading equipment qualification (IQ/OQ); ensuring compliance with ISO 13485 and FDA 21 CFR Part 820; executing PFMEA, CAPA, and root-ccause investigations; cross-functional collaboration with Operations, Quality, Supply Chain, and Design; applying Lean and Six Sigma to improve efficiency; training production teams on validated processes and monitoring requirements; supporting audits as SME. Location: Providence, RI with occasional travel.”,
Required Qualifications
- Bachelor's degree in Mechanical, Manufacturing, Industrial, Chemical Engineering, or a related field
- 3–5+ years in process engineering, manufacturing engineering, or operations engineering within a regulated industry; medical device experience strongly preferred
- Hands-on experience with process validation (IQ/OQ/PQ)
- Strong working knowledge of ISO 13485 and FDA 21 CFR Part 820 — must be able to serve as subject matter expert during audits
- Demonstrated expertise in DOE and Six Sigma methodology; Black Belt certification preferred
- Proficiency with Minitab or equivalent statistical software for capability analysis, SPC, and DOE
- Experience with CAPA and structured problem-solving methodologies
- Familiarity with plastic manufacturing processes, polymer materials, heat sealing, and packaging equipment
- Strong leadership skills with the ability to influence across Operations, Quality, and Design
Desired Qualifications
- Six Sigma Black Belt
- CQE
- CQA
- Advanced degrees or certifications in related fields
- Hands-on experience with process validation (IQ/OQ/PQ)
- Experience with DOE and capability analysis
- Experience with Minitab or equivalent statistical software
- Experience with CAPA and structured problem-solving methodologies
- Experience in medical device manufacturing
- Regulatory audit experience (ISO 13485, FDA 21 CFR Part 820)
- Lean Manufacturing and Six Sigma principles
- Training production teams on validated processes and in-process monitoring
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