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.

Key Responsibilities

Product & Process Development

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

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

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

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

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

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

Core Technical Competencies

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

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• Structured problem solving (root cause analysis, hypothesis-driven investigation)
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• Experimental design and validation of design/process changes
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• Data analysis and technical decision-making under uncertainty
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• Ability to balance design intent with manufacturability constraints
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Project & Technical Leadership (Senior Level Emphasis)

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• Ability to independently lead technical workstreams or device development activities
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• Coordinates cross-functional inputs and drives alignment on technical decisions
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• Mentors or guides junior engineers and technical contributors
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• Manages priorities across multiple development activities with minimal oversight
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Communication & Collaboration

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

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

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• Bachelor's degree in Biomedical Engineering, Mechanical Engineering, Materials Science, or related field
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• Hands-on experience with ePTFE materials, processing, or device applications
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• Strong understanding of polymer/fluoropolymer material behavior
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• Experience in medical device development within an ISO 13485 environment
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• Demonstrated ability to design experiments and analyze technical data
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• Strong written and verbal communication skills
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Preferred Qualifications

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• Experience with vascular, implantable, or catheter-based medical devices
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• Exposure to supplier qualification and raw material specification development
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• Experience participating in or leading design FMEAs or risk management activities
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• Prior experience mentoring engineers or leading technical projects/workstreams
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Role Progression Expectation (Engineer II → Senior Engineer)

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• Engineer II: Executes defined work independently, supports design/test activities, contributes to documentation and analysis
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• Senior Engineer: Leads technical workstreams, drives design/process decisions, mentors others, and owns deliverables from concept through validation
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Acknowledgement

I have received a copy of this job description, have read and understood it, and will complete all assigned duties and responsibilities. I recognize that the company reserves the right to modify this job description and that I will be informed of any and all modifications prior to their effective date.

Employee Signature

Date