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 → 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

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.
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