EPTFE Engineer

We are seeking a Medical Device Engineer with developing to advanced expertise in expanded PTFE (ePTFE) materials and device applications. This role supports and/or leads the design, development, and commercialization of ePTFE-based medical devices and components used in implantable and catheter-based systems.

The role spans from independent contributor (Engineer II) through technical project leadership (Senior Engineer), with increasing responsibility for design ownership, cross‑functional leadership, and workstream execution.

This position operates in a regulated ISO 13485 environment and partners closely with R&D, Quality, Operations, Regulatory, and external suppliers to deliver safe, effective, and manufacturable medical products.

• Contribute to or lead design and development of ePTFE-based medical devices and components from concept through commercialization
• Develop, optimize, and scale manufacturing processes for ePTFE constructs (tubes, films, sheets, grafts, and custom geometries)
• Translate user needs and design inputs into robust, manufacturable design outputs

• Design and execute material and device-level test methods including:
  • Tensile and mechanical testing
  • Burst pressure and leak testing
  • Suture retention
  • Permeability and porosity characterization
• Interpret data and drive design or process improvements based on results

• Support supplier engagement, development, and qualification activities
• Define and maintain raw material specifications for ePTFE and related components
• Partner with suppliers to resolve material variability and process capability issues

• Participate in design and process risk management activities (e.g., FMEA, material risk assessments)
• Ensure design controls and documentation comply with ISO 13485 and applicable regulatory requirements
• Support audit readiness and regulatory submissions as needed

• Develop and maintain design history file (DHF) documentation, protocols, reports, and technical summaries
• Communicate technical findings clearly across R&D, Quality, Operations, and external partners
• Support customer and internal technical discussions as required

• Lead structured problem-solving activities using data-driven methodologies
• Troubleshoot product and process issues through root cause analysis and corrective actions
• Drive closure of technical issues with appropriate urgency and rigor

• Deep understanding of ePTFE structure–property relationships and processing behavior
• Strong foundation in materials science (especially fluoropolymers)
• Knowledge of mechanical behavior of porous and expanded polymer systems
• Ability to design experiments (DOE mindset) and interpret statistical/engineering data
• Familiarity with medical device design controls and ISO 13485 systems

• Structured problem solving (root cause analysis, hypothesis‑driven investigation)
• Experimental design and validation of design/process changes
• Data analysis and technical decision‑making under uncertainty
• Ability to balance design intent with manufacturability constraints

• Ability to independently lead technical work streams or device development activities
• Coordinates cross‑functional inputs and drives alignment on technical decisions
• Mentors or guides junior engineers and technical contributors
• Manages priorities across multiple development activities with minimal oversight

• Clear and concise technical writing for regulated documentation
• Effective communication across R&D, Quality, Operations, and suppliers
• Ability to present technical rationale to internal stakeholders and customers
• Collaborative mindset with strong ownership and accountability

• Strong understanding of design controls, risk management, and validation expectations
• Consistent attention to detail in documentation and traceability
• Commitment to compliance and product quality in a regulated environment