Senior Process Engineer, Medical Devices — Validation

Management Recruiters of Tallahassee; Providence (RI); Vor Ort; USD 95.000 - 125.000; Vollzeit

Jobbeschreibung

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.
• 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.

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.