Extrusion Engineer – Medical Devices

We are seeking an experienced Extrusion Engineer to support the development, optimization, and manufacturing of polymer-based components used in medical devices. This role will have a strong hands-on focus across process development, new equipment implementation, product improvement, and manufacturing support.

The engineer will work closely with cross-functional teams including R&D, Operations, Quality, and Supply Chain to develop robust processes and improve the performance, consistency, and manufacturability of polymer components.

Responsibilities of the Extrusion Engineer:

• Lead engineering activities related to the development, qualification, and ongoing improvement of polymer extrusion processes.

• Develop and optimize tubing and other polymer-based components based on product performance and functional requirements.

• Support development of complex tubing configurations, including multi-lumen, reinforced, layered, lined, and variable-durometer constructions.

• Evaluate polymers and material systems and determine appropriate processing approaches for new and existing products.

• Apply statistical methods and data analysis to characterize processes, identify sources of variation, and improve process capability.

• Develop and optimize extrusion processes, tooling, equipment settings, and material handling methods.

• Support forming and secondary processing operations associated with polymer components.

• Specify, evaluate, install, and qualify manufacturing equipment, tooling, fixtures, and related systems.

• Lead efforts to improve process stability, yield, throughput, and overall manufacturing efficiency.

• Troubleshoot manufacturing and process issues and implement corrective and preventive improvements.

• Partner with external suppliers and manufacturers on materials, tooling, processing capabilities, and component sourcing.

• Work effectively across R&D, Manufacturing, Quality, and Supply Chain to support new product introduction and sustaining activities.

• Participate in projects involving equipment procurement, fabrication, installation, process development, and validation.

• Bachelor’s degree in Materials Engineering, Plastics Engineering, Chemical Engineering, Mechanical Engineering, or a related technical discipline.

• 5+ years of hands-on experience with polymer extrusion, preferably involving complex tubing or small-diameter components.

• Strong understanding of polymer processing, material behavior, tooling, and extrusion equipment.

• Experience developing and scaling extrusion processes from development through manufacturing.

• Experience with a range of thermoplastic materials and polymer systems.

• Familiarity with reinforced, multi-layer, multi-lumen, lined, or multi-durometer tubing is highly desirable.

• Experience with process characterization, statistical analysis, and process capability improvement.

• Demonstrated ability to troubleshoot equipment and manufacturing processes.

• Prior experience working in a regulated manufacturing environment; medical device experience strongly preferred.

• Experience with process qualification, equipment validation, and manufacturing documentation.