Develop, optimize, validate, and troubleshoot precision polymer extrusion processes for medical tubing (multi-lumen, taper, co-extrusion, balloon). Operate and maintain extrusion equipment, prepare process and validation documentation (IQ/OQ/PQ), support tooling vendors, train production staff, ensure quality and regulatory compliance, and lead continuous improvement in extrusion operations.
We are seeking an experienced Medical Device Extrusion Process Engineer/Specialist with hands-on expertise in precision polymer extrusion and medical tubing. The successful candidate will be responsible for developing, optimizing, troubleshooting, and validating extrusion processes while ensuring products meet strict quality, regulatory, and customer requirements.
Key Responsibilities
- Develop, implement, and optimize extrusion processes for high-precision medical device tubing.
- Set up, operate, tear down, and oversee polymer extrusion equipment and tooling.
- Execute complex extrusion processes including multi-lumen, taper tubing, co-extrusion, and balloon tubing.
- Troubleshoot extrusion processes, equipment, tooling, and processing parameters to minimize defects, scrap, and downtime.
- Work closely with Production, R&D, Engineering, Quality, and Manufacturing teams during product development, prototyping, and production release.
- Develop and optimize process parameters to achieve required product profiles, tolerances, and quality specifications.
- Support tooling and fixture development with external vendors.
- Prepare and maintain extrusion run documentation, process records, traceability records, and regulatory documentation.
- Write and execute IQ/OQ/PQ process and equipment validations.
- Provide technical support, coaching, and training to production personnel.
- Oversee equipment maintenance and ensure extrusion equipment operates at optimal conditions.
- Support continuous improvement initiatives focused on scrap reduction, productivity, cost savings, quality, and process optimization.
- Ensure compliance with company Health & Safety policies and Quality Management System requirements.
- Maintain a clean, organized, and contamination-controlled work environment.
- Support the development and supervision of the Extrusion Department.
Required Qualifications & Experience
- Post-secondary education in Engineering, Polymer/Plastics Technology, Manufacturing, or a related technical field, or equivalent technical experience.
- Minimum 5 years of hands-on precision extrusion experience in a medical device manufacturing environment.
- Strong experience setting up and running extrusion equipment for medical-grade products.
- Proven experience with multi-lumen, taper tubing, co-extrusion, and/or balloon tubing.
- Extensive knowledge of polymer extrusion, including materials such as Pebax, Arnitel, Hytrel, PET, PU, HDPE, LDPE, PBT, Polypropylene, and Nylon.
- Strong understanding of extrusion tooling, die design, equipment design, and process parameters.
- Expert understanding of how viscosity, velocity, moisture, and resin degradation affect extrusion profiles and multi-lumen products.
- Strong knowledge of process instrumentation and its relationship to extrusion performance.
- Experience with IQ/OQ/PQ validation and process documentation.
- Strong troubleshooting, analytical, and problem-solving skills.
- Ability to work independently and effectively within cross-functional teams.
- Strong communication, organization, and time-management skills.
- Proficiency with computers, spreadsheets, databases, and word-processing applications.
AI-enabled tools may be used to sort applications based on job-related criteria. All AI generated results are vetted by our team and the decision of which candidates move forward is always made by a human.
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