ePTFE Engineer

About the role

We are seeking a Medical Device Engineer with 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 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.

Responsibilities

• Product & Process Development: 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.
• Testing & Characterization: Design and execute material and device‑level test methods, including tensile and mechanical testing, burst pressure and leak testing, suture retention, and permeability/porosity characterization; interpret data and drive design or process improvements based on results.
• Supplier & Material Management: 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.
• Risk & Compliance: 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.
• Technical Documentation & Communication: 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.
• Problem Solving & Execution: 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.

Competency Framework

• Core Technical Competencies: 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.
• Engineering Execution Competencies: 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.
• Project & Technical Leadership (Senior Level Emphasis): Ability to independently lead technical workstreams or device development activities; coordinate cross‑functional inputs and drive alignment on technical decisions; mentor or guide junior engineers and technical contributors; manage priorities across multiple development activities with minimal oversight.
• Communication & Collaboration: 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.
• Quality & Regulatory Mindset: 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.

Qualifications

• Required:
  • Bachelor’s degree in Biomedical Engineering, Mechanical Engineering, Materials Science, or a 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.
• Preferred:
  • Experience with vascular, implantable, or catheter‑based medical devices.
  • Exposure to supplier qualification and raw material specification development.
  • Experience participating in or leading design FMEAs or risk management activities.
  • Prior experience mentoring engineers or leading technical projects/workstreams.

Role Progression

Engineer II: Executes defined work independently, supports design/test activities, contributes to documentation and analysis.

Senior Engineer: Leads technical workstreams, drives design/process decisions, mentors others, and owns deliverables from concept through validation.