Cordis
Fluoropolymer Extrusion Engineer (Onsite)
Fluoropolymer Extrusion Engineer (Onsite)
– Cordis
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, Cordis is dedicated to being the heart of innovation to transform cardiovascular care. We embrace an empowered, one‑team culture where teammates unleash their full potential and share diverse experiences to enhance careers, service and patient lives.
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 Requires Engineering Bachelor’s Degree and 8+ years of relevant experience or Master’s Degree and 6+ years of relevant 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 diverse strengths, experiences, and backgrounds, and believe inclusion is everyone's responsibility.
Seniority level Mid‑Senior level
Employment type Full‑time
Job function Engineering and Information Technology
Industries Medical Equipment Manufacturing
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– Cordis
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, Cordis is dedicated to being the heart of innovation to transform cardiovascular care. We embrace an empowered, one‑team culture where teammates unleash their full potential and share diverse experiences to enhance careers, service and patient lives.
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 Requires Engineering Bachelor’s Degree and 8+ years of relevant experience or Master’s Degree and 6+ years of relevant 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 diverse strengths, experiences, and backgrounds, and believe inclusion is everyone's responsibility.
Seniority level Mid‑Senior level
Employment type Full‑time
Job function Engineering and Information Technology
Industries Medical Equipment Manufacturing
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