Job Summary:
We are seeking an experienced and detail-oriented Extrusion Process Engineer with a strong background in medical extrusion to join our team. The ideal candidate will be responsible for developing, optimizing, and troubleshooting extrusion processes for medical-grade tubing and components. This role requires expertise in polymer processing, equipment troubleshooting, and continuous improvement methodologies to ensure the highest quality standards for medical devices. This position features relocation assistance if needed.
Responsibilities:
Develop, optimize, and validate extrusion processes for medical tubing, catheter components, and other polymer-based medical products.
Monitor and troubleshoot extrusion equipment (e.g., single-screw and twin-screw extruders) to ensure optimal performance and product quality.
Select and evaluate medical-grade polymers (e.g., PTFE, PEEK, Pebax, Polyurethane, Silicone) for extrusion applications.
Design and implement process improvements to enhance efficiency, reduce waste, and improve yield.
Develop process documentation, including standard operating procedures (SOPs), work instructions, and validation protocols.
Lead process validation activities (IQ, OQ, PQ) to ensure compliance with FDA, ISO 13485, and GMP regulations.
Collaborate with R&D, Quality, and Manufacturing teams to scale up new products from prototype to full production.
Conduct root cause analysis and implement corrective actions for process deviations or quality issues.
Work with tooling engineers to design extrusion dies, screws, and downstream equipment for optimized performance.
Train operators and production staff on best practices for extrusion processing and equipment operation.
