Process Engineer

Process Engineer Nelipak Healthcare Packaging - 2.8 Cranston, RI Job Details Full-time $90,000 - $120,000 a year 1 hour ago Benefits Relocation assistance Qualifications Statistical Process Control Minitab Attention to detail Industrial engineering FDA regulations Full Job Description Job Summary We are seeking a highly motivated and detail-oriented Process Engineer to optimize manufacturing operations and enhance production efficiency. The ideal candidate will possess a strong background in industrial engineering, process development, and manufacturing systems, with expertise in process improvement methodologies and technical design tools. The Process Engineer ensures robust manufacturing processes are developed, validated, and maintained in compliance with customer, regulatory, and industry requirements. This role owns the validated state of thermoforming and sealing processes, working closely with the Design Quality Engineer, Operations, and Quality teams to establish and sustain process capability across Nelipak's Americas operations. The Process Engineer 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 Duties Develop and execute Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols for thermoforming and sealing processes per 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), ensuring a minimum Cpk of 1.33 for critical parameters. o Define, optimize, and standardize thermoforming process parameters including temperature profiles, vacuum/pressure settings, plug assist timing, and cycle times. Collaborate with tooling and design teams on Design for Manufacturability (DFM) assessments for new product introductions. Lead scale-up activities from development to full production, ensuring process robustness and reproducibility. Evaluate polymer material behavior and thermal characteristics to optimize forming and sealing performance. Use Minitab or equivalent software for DOE, capability studies, SPC, Gage R&R, and process data analysis to support data-driven decision-making. Design and conduct Design of Experiments to characterize process behavior, identify critical factor interactions, and optimize process windows. Implement and maintain Statistical Process Control (SPC) programs including control charting, trend analysis, and out-of-control response protocols. Perform measurement system analysis (Gage R&R) to ensure measurement capability supports process monitoring requirements. o Ensure all processes comply with

ISO 13485, ISO 11607-1/2, FDA 21 CFR

Part 820 (QMSR), and

GHTF/SG3

process validation guidance. Participate in internal, customer, and regulatory audits as the subject matter expert for process validation and manufacturing controls. Support change control processes by evaluating process impact, determining re-validation requirements, and ensuring documentation compliance. Identify and lead process improvement initiatives to reduce scrap, cycle time, and cost while maintaining or improving quality. Drive root cause investigations using structured methodologies (5-Why, Fishbone, DMAIC) and implement corrective and preventive actions (CAPA). Collaborate with manufacturing teams to optimize production processes and ensure validated process intent is maintained during daily operations. Apply Lean Manufacturing and Six Sigma principles to eliminate waste and improve process efficiency. Skills Proficiency with statistical software such as Minitab for process capability analysis, SPC, DOE, and validation data analysis. Strong understanding of DOE methodology, process capability analysis (Cpk/Ppk), and statistical process control principles. Knowledge of

ISO 13485, ISO 11607-1/2, FDA 21 CFR

Part 820 (QMSR), and

FDA/GHTF

process validation guidance. Experience with process validation lifecycle (IQ/OQ/PQ) and continued process verification (Stage 3). Experience with PFMEA, CAPA, root cause analysis tools, and structured problem-solving methodologies. Familiarity with thermoforming processes, polymer materials, heat sealing, and packaging equipment technologies. Excellent problem-solving, project management, and technical communication skills. Ability to work collaboratively across operations, engineering, quality, and supply chain functions.

Pay:

$90,000.00 - $120,000.00 per year

Benefits:

Relocation assistance People with a criminal record are encouraged to apply

Work Location:

In person