Cordis · 2 days ago
Fluoropolymer Extrusion Engineer (Onsite)
Miami Lakes, FL
Full-time
Onsite
Senior Level
6+ years expCordis is a global leader in cardiovascular and endovascular technology, dedicated to transforming cardiovascular care. The Senior Extrusion Engineer will focus on polymer and fluoropolymer extrusion for medical device components, leading process optimization and validation in a regulated environment.
Health CareHealth DiagnosticsMedical
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
Qualification
Required
Requires Engineering Bachelors Degree and 8+ years of relevant experience or Master's Degree and 6+ years of relevant experience
Preferred
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
Company
Cordis
Cordis Corporation, a Johnson & Johnson company, has pioneered less invasive treatments for vascular disease.
1001-5000 employees
H1B Sponsorship
Cordis has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (5)
2024 (3)
2023 (3)
2022 (4)
Funding
Current Stage
Late StageTotal Funding
unknown2021-03-12Acquired
Leadership Team
Scott Drake
Chief Executive Officer
Recent News
2025-11-11
TeamBest Global Companies
2025-11-07
News-Medical.Net
2025-11-01
Company data provided by crunchbase