Senior Process Engineer

Crosslinked; Providence (NC); On-site; USD 110,000 - 150,000; Full time

Benefits offered by this job

401(k) match program

Dental, health, and vision insurance

Paid time off

Job summary

Crosslinked is seeking a Senior Process Engineer for its Providence, RI location to validate and optimize thermoforming and heat-sealing processes for medical device packaging components. You will lead IQ/OQ/PQ validation activities, define CPPs/NOR, and drive continuous improvement across Operations, Quality, and Design teams.

The role requires 3–5+ years in a regulated environment, working knowledge of ISO 13485 and FDA 21 CFR Part 820, and strong DOE/Six Sigma capabilities.

Qualifications

• 3–5+ years in process/ manufacturing engineering within a regulated industry (medical device preferred).
• Experience with IQ/OQ/PQ validation in FDA/ISO contexts.
• Strong knowledge of ISO 13485 and FDA 21 CFR Part 820; audit SME capabilities.
• Demonstrated DOE and Six Sigma expertise; Black Belt preferred.
• Proficiency with Minitab for capability analysis, SPC, and DOE; CAPA experience.

Responsibilities

• Develop and execute IQ/OQ/PQ validation protocols for thermoforming and sealing processes per ISO 11607-2 and FDA guidance.
• Define CPPs, PAR, and NOR through structured development studies and DOE.
• Lead statistical analysis of validation data; target Cpk ≥ 1.33 for critical parameters.
• Own full three-stage validation lifecycle: Process Design, Qualification, and Continued Verification.
• Define and optimize process parameters (temperature, vacuum/pressure, 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; serve as audit SME.
• Use Minitab or equivalent for DOE, capability, SPC, Gage R&R, data analysis.
• Lead PFMEA, CAPA, and root cause investigations; apply structured problem-solving.
• Collaborate cross-functionally to align process improvements with business needs.
• Train production teams on validated processes and in-process monitoring.

Skills

DOE

Six Sigma

Minitab

Gage R&R

SPC

CAPA

Root Cause Analysis

Lean Manufacturing

Leadership

Education

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

Tools

Minitab

Job description

Crosslinked

Jobs/Thermoplastics/Senior Process Engineer

One of 4,492 polymer and materials roles on Crosslinked, each read for materials, degree, visa and salary. See roles like this

MR

Senior Process Engineer

Management Recruiters of Tallahassee

BS-level Process Engineering roles on Crosslinked list a median of $112k (559 that show pay). This posting does not list pay.

Validate and optimize thermoforming and heat-sealing processes for medical device packaging components.

Thermoplastics

Why it is interesting.

Deep validation ownership — CPP/PAR/NOR definition, Cpk targets, and audit SME duties under ISO 11607 and 21 CFR 820.

Might not be for you.

Heavy documentation and audit-facing compliance work; process optimization rather than materials R&D.

Adjacent materials roleFamiliarity with plastic manufacturing processes, polymer materials, heat sealing, and packaging equipment; thermoforming and sealing processes

Seniority Senior

Work On-site

Type Full-time

Degree BS

Experience 3–5 yrs

Industry Medical devices

Role Process Engineering

Materials

polymer materials10 roles

Role details

Title: Senior 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 Senior 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 Senior 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 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.

Benefits

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

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

*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.*

Common questions

Where is the Senior Process Engineer role at Management Recruiters of Tallahassee based?

This role is based in Providence, RI.

What degree is required for the Senior Process Engineer role at Management Recruiters of Tallahassee?

This role requires a BS.

How many years of experience does this Senior Process Engineer role require?

The posting calls for 3–5 years of relevant experience.

What polymers or materials does this Senior Process Engineer role work with?

polymer materials.

What techniques or methods are required for this Senior Process Engineer role?

DOE, SPC, Gage R&R, process capability (Cpk).