Fluoropolymer Extrusion Engineer (Onsite)

Cordis•Miami Lakes, FL

3d•Onsite

About The Position

When you join the team at Cordis, you become part of an inspiring mission to save lives, impacting millions of people and broadening access to life-saving cardiovascular and endovascular technology. As a global leader for over 60 years, we are dedicated to being the heart of innovation to transform cardiovascular care. At Cordis, we're teammates, not just employees. We embrace an empowered and one-team culture where teammates are inspired to unleash their full potential. With diverse teams on a global scale, we believe the richness of our experiences and backgrounds enhances the careers of our teammates, the service to our customers, and ultimately, the lives of our patients. If you love a challenge and are ready to have a direct, transformative and positive impact on the lives of millions, then Cordis is just the place for you. We are the people behind the people who keep saving lives. Position Summary We are seeking a highly skilled Senior Extrusion Engineer to join our team. This role will focus on polymer and fluoropolymer extrusion for critical medical device components and catheter shaft assemblies. The ideal candidate has hands-on experience with extrusion process development, optimization, and validation in a regulated medical device environment.

Requirements

Requires Engineering Bachelors Degree and 8+ years of relevant experience or Master's Degree and 6+ years of relevant experience

Responsibilities

Develop and optimize extrusion processes for polymer and fluoropolymer materials (e.g., PTFE, FEP, PFA, ETFE, PEBAX, polyurethane, nylon).
Design and validate extrusion tooling and equipment for single- and multi-lumen tubing, thin-wall profiles, co-extrusions, and balloon films.
Lead process validation (IQ/OQ/PQ) activities, ensuring compliance with ISO 13485 and FDA QSR requirements.
Troubleshoot and resolve extrusion process issues, ensuring dimensional accuracy, mechanical performance, and surface quality.
Collaborate with R D to transfer new designs into scalable, high-quality extrusion processes.
Partner with suppliers on raw material evaluations, resin selection, and fluoropolymer processing methods.
Apply statistical tools (DOE, SPC, FMEA, root cause analysis) to drive process improvement and reduce scrap/waste.
Document and maintain all manufacturing procedures, work instructions, and process control records.
Support capital equipment procurement, installation, and qualification for new extrusion lines.
Provide technical training and mentoring to production staff.