Production & Process Engineering

Process Engineer

Our client, a leading global company specializing in custom solutions for the medical device and pharmaceutical industries, is seeking a Process Engineer for its Providence, RI location. The company designs and manufactures custom components using advanced plastic manufacturing technology and rigorous quality control standards.

The Process Engineer works closely with Operations, Quality, and Design teams to establish and sustain process capability across the company's Americas operations. This role applies engineering principles, statistical methods, and process development expertise to optimize product quality, ensure regulatory compliance, and drive continuous improvement from development through full-scale production.

Define critical process parameters (CPPs), Proven Acceptable Ranges (PAR), and Normal Operating Ranges (NOR) through structured development studies and DOE.

Lead statistical analysis of validation data including process capability (Cpk), targeting a minimum Cpk of 1.33 for critical parameters.

Lead equipment qualification (IQ/OQ) for supporting equipment.

serve as subject matter expert during internal, customer, and regulatory audits.

Use Minitab or equivalent software for DOE, capability studies, SPC, Gage R&R, and process data analysis.

Lead PFMEA, CAPA, and root cause investigations using structured methodologies (5-Why, Fishbone, DMAIC).

Partner cross-functionally with Operations, Quality, Supply Chain, and Design to align process improvements with business and customer requirements.

Train production teams on validated processes, in-process monitoring requirements, and critical quality attributes.

Apply Lean Manufacturing and Six Sigma principles to eliminate waste and improve process efficiency.

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.

• Strong working knowledge of ISO 13485 and FDA 21 CFR Part 820 — must be able to serve as subject matter expert during audits.
• 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.

Dental, health, and vision insurance

~ Providence, RI — occasional travel to other sites may be required.