Senior Process Engineer

Crosslinked Jobs/Thermoplastics/Senior Process Engineer One of 4,539 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 Providence, RItodayverified 2 h ago BS-level Process Engineering roles on Crosslinked list a median of $112k (567 that show pay). This posting does not list pay. Validate and optimize thermoforming and heat-sealing processes for medical device packaging components. Apply Thermoplastics Process Engineering roles, by email Apply Worth knowing 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. Bench and deskDeep specialistMethodical pace BS acceptableSenior hires only Realistic requirements 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 Techniques DOE231 rolesSPC229 rolesGage R&R27 rolesprocess capability (Cpk)1 role 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 programDental, health, and vision insurancePaid 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 matthew@mrrecruiter.com. *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.* Connected All roles at Management Recruiters of TallahasseeMore Process Engineering rolesRoles using DOEThermoplastics roles Related roles MP Process Improvement EngineerMOS Plastics Inc. (Currier) San Jose, CA BA Project EngineerBrightpath Associates LLC Akron, OH SA Mold Qualification EngineerSystems Ally Minneapolis, MN BI Packaging Application Engineer - Pressure SensitiveBelmark Inc De Pere, WI OP Injection Equipment & Process Performance EngineerOPmobility Greer, SC 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).