ePTFE Engineer
On-site · Charlotte, North Carolina, United States
Job Summary
ePTFE Engineer sought to advance the design, development, and commercialization of ePTFE-based medical devices and components for implantable and catheter-based systems. Role spans from independent contributor (Engineer II) to technical leadership (Senior Engineer), in a regulated ISO 13485 environment, collaborating with R&D, Quality, Operations, Regulatory, and suppliers. Responsibilities include leading design and development, optimizing manufacturing processes for ePTFE constructs, executing material and device testing, managing supplier qualification, participating in risk management (FMEA) and design controls, maintaining DHF/control documentation, and driving data-driven problem-solving and cross-functional technical communication.
Required Qualifications
- Bachelor's degree in Biomedical Engineering, Mechanical Engineering, Materials Science, or related field
- Hands-on experience with ePTFE materials, processing, or device applications
- Strong understanding of polymer/fluoropolymer material behavior
- Experience in medical device development within an ISO 13485 environment
- Demonstrated ability to design experiments and analyze technical data
- Strong written and verbal communication skills
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