Manufacturing Process Engineer

Management Recruiters of Tallahassee; Providence (RI); On-site; USD 80,000 - 100,000; Full time

Benefits offered by this job

401(k) match program

Dental insurance

Health insurance

Vision insurance

Paid time off

Job summary

Management Recruiters of Tallahassee is hiring a Process Engineer in Providence, RI. This role involves working closely with Operations and Quality teams to optimize product quality and compliance in manufacturing processes.

The ideal candidate will have 3-5+ years in process engineering, expertise in ISO standards, and proficiency in Minitab. Key responsibilities include developing validation protocols and training production teams. Benefits include 401(k) match and health insurance.

Qualifications

• 3-5+ years in process engineering within a regulated industry; medical device experience preferred.
• Strong knowledge of ISO 13485 and FDA 21 CFR Part 820.
• Demonstrated expertise in DOE and Six Sigma methodology.

Responsibilities

• Develop and execute validation protocols for thermoforming and sealing processes.
• Lead statistical analysis of validation data for critical parameters.
• Train production teams on validated processes and critical quality attributes.

Skills

Process validation (IQ/OQ/PQ)

Statistical analysis

Lean Manufacturing

Six Sigma methodology

Minitab or equivalent software

Root cause investigations

Leadership skills

Education

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

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

Tools

Minitab

Heat sealing equipment

Statistical Process Control (SPC)

Job description

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), targeting a 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.
• Ensure all processes comply 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 a 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 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.
• 401(k) match program
• Dental, health, and vision insurance
• Paid time off

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].

Equal Opportunity Employer Disclaimer

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.