Staff Fluoropolymer Extrusion Engineer (Onsite)

Overview 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. Responsibilities Position Summary: We are seeking a highly skilled 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. Key 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. Qualifications Required Qualifications : Requires Engineering Bachelors Degree and 8+ years of relevant experience or Master's Degree and 6+ years of experience. Preferred Qualifications Bachelor's degree in Polymer Engineering, Materials Science, Mechanical Engineering, Biomedical Engineering, or related field (Master's preferred). 8+ years of hands‑on extrusion engineering experience in the medical device industry or regulated manufacturing environment. Demonstrated expertise in polymer and fluoropolymer extrusion (PTFE, FEP, ETFE, etc.). Knowledge of extrusion tooling design, die design, and equipment setup. Experience with cleanroom manufacturing and compliance to ISO 13485 and FDA 21 CFR Part 11/QSR. Proficiency with statistical analysis tools and process validation methodologies. Skills & Attributes Strong problem‑solving and analytical skills. Ability to manage multiple projects in a fast‑paced, regulated environment. Excellent written and verbal communication skills. Collaborative team player with attention to detail. Equal Opportunity Employer / Protected Veterans / Individuals with Disabilities Cordis is proud to be an equal opportunity employer and is committed to providing equal opportunity for all teammates and applicants. We value diversity in all its forms and are committed to fostering an inclusive work environment. Our team is invested in attracting, retaining, and growing top talent. We are committed to offering reasonable accommodations upon request to job applicants with disabilities. If you need assistance or an accommodation due to a disability, please contact View email address on click.appcast.io . #J-18808-Ljbffr 6AM City, LLC