ePTFE Engineer

Aptyx; Charlotte (NC); On-site; USD 80,000 - 100,000; Full time

Job summary

Aptyx is seeking a Medical Device Engineer in Charlotte, NC, specializing in expanded PTFE materials for medical device applications. The role involves leading the design and development process while collaborating across functional teams in a regulated ISO 13485 environment.

The ideal candidate will possess a Bachelor's degree in Biomedical Engineering or related fields and have hands-on experience with ePTFE materials. Responsibilities include optimizing manufacturing processes and conducting rigorous device testing.

Qualifications

• Hands-on experience with ePTFE materials and applications.
• Strong understanding of polymer behavior.
• Experience in ISO 13485 regulated environments.

Responsibilities

• Lead design and development of ePTFE-based medical devices.
• Optimize manufacturing processes for ePTFE constructs.
• Conduct material and device-level testing.

Skills

Expertise in expanded PTFE (ePTFE)

Problem solving

Team collaboration

Technical communication

Education

Bachelor's degree in Biomedical Engineering

Mechanical Engineering

Materials Science

Tools

Materials testing equipment

Design tools (CAD)

Job description

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

• 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 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
• 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 to 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