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 commercializationDevelop, 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 outputsTesting & Characterization Design and execute material and device-level test methods including: Tensile and mechanical testingBurst pressure and leak testingSuture retentionPermeability and porosity characterizationInterpret data and drive design or process improvements based on resultsSupplier & Material Management Support supplier engagement, development, and qualification activitiesDefine and maintain raw material specifications for ePTFE and related componentsPartner with suppliers to resolve material variability and process capability issuesRisk & 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 requirementsSupport audit readiness and regulatory submissions as neededTechnical Documentation & Communication Develop and maintain design history file (DHF) documentation, protocols, reports, and technical summariesCommunicate technical findings clearly across R&D, Quality, Operations, and external partnersSupport customer and internal technical discussions as requiredProblem Solving & Execution Lead structured problem-solving activities using data-driven methodologiesTroubleshoot product and process issues through root cause analysis and corrective actionsDrive closure of technical issues with appropriate urgency and rigorCompetency Framework Core Technical Competencies Deep understanding of ePTFE structure–property relationships and processing behaviorStrong foundation in materials science (especially fluoropolymers)Knowledge of mechanical behavior of porous and expanded polymer systemsAbility to design experiments (DOE mindset) and interpret statistical/engineering dataFamiliarity with medical device design controls and ISO 13485 systemsEngineering Execution Competencies Structured problem solving (root cause analysis, hypothesis‑driven investigation)Experimental design and validation of design/process changesData analysis and technical decision‑making under uncertaintyAbility to balance design intent with manufacturability constraintsProject & Technical Leadership (Senior Level Emphasis) Ability to independently lead technical workstreams or device development activitiesCoordinates cross‑functional inputs and drives alignment on technical decisionsMentors or guides junior engineers and technical contributorsManages priorities across multiple development activities with minimal oversightCommunication & Collaboration Clear and concise technical writing for regulated documentationEffective communication across R&D, Quality, Operations, and suppliersAbility to present technical rationale to internal stakeholders and customersCollaborative mindset with strong ownership and accountabilityQuality & Regulatory Mindset Strong understanding of design controls, risk management, and validation expectationsConsistent attention to detail in documentation and traceabilityCommitment to compliance and product quality in a regulated environmentRequired Qualifications Bachelor's degree in Biomedical Engineering, Mechanical Engineering, Materials Science, or related fieldHands‑on experience with ePTFE materials, processing, or device applicationsStrong understanding of polymer/fluoropolymer material behaviorExperience in medical device development within an ISO 13485 environmentDemonstrated ability to design experiments and analyze technical dataStrong written and verbal communication skillsPreferred Qualifications Experience with vascular, implantable, or catheter-based medical devicesExposure to supplier qualification and raw material specification developmentExperience participating in or leading design FMEAs or risk management activitiesPrior experience mentoring engineers or leading technical projects/workstreamsRole Progression Expectation (Engineer II to Senior Engineer) Engineer II: Executes defined work independently, supports design/test activities, contributes to documentation and analysisSenior Engineer: Leads technical workstreams, drives design/process decisions, mentors others, and owns deliverables from concept through validation#J-18808-Ljbffr