Process Engineer in Providence

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

Job DescriptionJob 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), 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.
• Lead equipment qualification (IQ/OQ) for supporting equipment.
• 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 .
• 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 .
• 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.

Benefits:

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

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

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 , , , , , or expression, , , 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.