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 .

Robust 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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📌 Extrusion Specialist (Engineer) (Prince Edward County)
🏢 Gilder Search Group
📍 Prince Edward County