Process Engineer

MRINetwork; Providence (RI); On-site; USD 75,000 - 95,000; Full time

Benefits offered by this job

401(k) match program

Dental, health, and vision insurance

Paid time off

Job summary

MRINetwork is seeking a Process Engineer located in Providence, RI, specializing in custom solutions for the medical device and pharmaceutical sectors. The role involves optimizing product quality and ensuring regulatory compliance through collaboration with various teams.

Qualified candidates will have a Bachelor’s degree in engineering and 3-5+ years of relevant experience. Benefits include a 401(k) match, diverse insurance options, and paid time off.

Qualifications

• 3–5+ years in process engineering, manufacturing engineering, or operations engineering.
• Hands-on experience with process validation (IQ/OQ/PQ).
• Strong knowledge of FDA regulations and ISO standards.

Responsibilities

• Develop and execute validation protocols for processes.
• Define critical process parameters through development studies.
• Lead statistical analysis of validation data.

Skills

ISO 13485 expertise

Six Sigma methodology

Minitab or equivalent software

Lean Manufacturing principles

Root-cause analysis

Education

Bachelor's degree in Mechanical, Manufacturing, Industrial, or Chemical Engineering

Advanced degrees or certifications (Six Sigma, CQE, CQA)

Tools

Minitab

Statistical analysis tools

Job description

Title: Process Engineer

Location: Providence, RI

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.

Position Overview

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.

Responsibilities and Functions

• Develop and execute IQ/OQ/PQ validation protocols for thermoforming and sealing processes in compliance with ISO 11607‑2 and FDA process‑validation guidance.
• 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) with a mandatory minimum Cpk of 1.33 for critical parameters.
• Own the full three‑stage validation lifecycle: Process Design, Process Qualification, and Continued Process Verification.
• Define, optimize, and standardize process parameters including temperature profiles, vacuum/pressure settings, plug‑assist timing, and cycle times.
• Lead equipment qualification (IQ/OQ) for supporting equipment.
• Ensure compliance with ISO 13485, ISO 11607‑1/2, and FDA 21 CFR Part 820 (QMSR); 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.

Qualifications

Education

• Bachelor's degree in Mechanical, Manufacturing, Industrial, Chemical Engineering, or related field. Advanced degrees or certifications (Six Sigma, CQE, CQA) are a plus.

Experience

• 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 knowledge of ISO 13485 and FDA 21 CFR Part 820 – must serve as subject‑matter expert during audits.
• Proven 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 ability to influence across Operations, Quality, and Design.

Benefits

• 401(k) match program
• Dental, health, and vision insurance
• Paid time off

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

If you are interested in this position, please apply here or send your resume to [e-mail].

This organization is an Equal Opportunity Employer and is committed to creating an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability status, genetic information, protected veteran status, or any other characteristic protected by applicable law. Employment decisions are based solely on qualifications, merit, and business needs.