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 ResponsibilitiesProduct & 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
- Permeability and 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 FrameworkCore 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
- 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
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
Required Qualifications- Bachelor's degree in Biomedical Engineering, Mechanical Engineering, Materials Science, or 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 Qualifications- 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 Expectation (Engineer II 14 Senior Engineer)- 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
AcknowledgementI 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.
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