R&D Engineer ePTFE (Med Device)
Key Responsibilities
- Contribute to or lead the design and development of devices that incorporate ePTFE, including concept generation, prototyping, process development, and design refinement.
- Develop and optimize manufacturing processes for ePTFE constructs such as tubes, films, sheets, grafts, and custom structures.
- Create and execute material and device level test methods including tensile testing, burst strength, leak testing, suture retention, and permeability characterization.
- Support supplier engagement, raw material qualification, and specification development.
- Participate in risk management activities including design failure mode analysis and material risk assessments.
- Prepare clear technical documentation including design histories, protocols, reports, and regulatory support files.
- Work closely with the R&D team, quality, operations, and customers to ensure products meet user needs and comply with relevant standards.
- Troubleshoot product and process issues through structured problem solving and data driven analysis.
- Bachelor's degree in biomedical engineering, mechanical engineering, materials science, or a related discipline.
- Hands-on experience working with ePTFE materials and processes.
- Strong understanding of materials science principles related to fluoropolymers.
- Experience in medical device development within an ISO 13485 environment.
- Ability to design experiments, analyze data, and propose clear next steps.
- Strong written and verbal communication skills.
Preferred Qualifications
- Experience with vascular, implantable, or catheter based devices.
- Prior exposure to supplier qualification and raw material specification development.
- Familiarity with device level risk management activities.
- Experience leading technical workstreams or mentoring junior engineers.
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