Process Engineer
Harba Solutions Inc.
Overview
The Process Engineer supports plastics manufacturing operations in a medical device manufacturing environment by optimizing manufacturing processes, troubleshooting equipment and process issues, and driving continuous improvement initiatives. This role partners with Operations, Quality, Maintenance, and Engineering to improve safety, product quality, production efficiency, and cost performance while supporting equipment reliability and manufacturing readiness.
Job Requirements
- Develop, optimize, and maintain injection molding, blow molding, automation, and secondary manufacturing processes.
- Troubleshoot process, equipment, tooling, material, and automation issues using structured problem-solving methods and manufacturing data.
- Lead root cause investigations for quality defects, process deviations, equipment issues, and customer complaints.
- Analyze process capability, reduce scrap, improve production yield, and maximize overall equipment effectiveness (OEE).
- Drive corrective and preventive actions and continuous improvement initiatives focused on cycle time reduction, waste elimination, labor efficiency, capacity expansion, and cost reduction.
- Support manufacturing equipment and process lifecycle activities, including validation, qualification, installation, commissioning, startup, and operational readiness.
- Partner with Operations, Maintenance, Quality, Supply Chain, equipment suppliers, mold manufacturers, and automation integrators to establish process standards and improve manufacturing performance.
- Support new product introductions, engineering changes, and manufacturing process improvements.
- Apply statistical analysis and problem-solving methodologies to identify process variation and implement data-driven solutions.
- Support process validation, IQ/OQ/PQ execution, equipment qualification, CAPA investigations, and nonconformance investigations in regulated manufacturing environments.
- Contribute to equipment installations, automation integration, manufacturing expansions, and production improvement projects.
- Maintain a strong focus on safety, quality, continuous improvement, and long-term process reliability.
Job Qualifications
- Bachelor's degree in Engineering, including Chemical, Mechanical, Manufacturing, Process, Industrial, Plastics, or a related field.
- 3+ years of industry engineering experience in applicable area of expertise.
- Experience with plastics manufacturing processes, including injection molding, blow molding, and mold qualification.
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