R&D Engineer ePTFE (Med Device)

Aptyx • Charlotte, NC

2d

About The Position

We are seeking an engineer with growing to advanced expertise in expanded PTFE devices. This role supports and leads product development efforts for components that rely on the unique structural and mechanical behavior of ePTFE. The position ranges from an independent technical contributor at the Engineer II level to project level leadership at the Senior Engineer level.

Requirements

• 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.

Nice To Haves

• 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.

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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level