Catheter R&D Engineer
il y a 11 jours
Charlotte
Job Description Aptyx is seeking a highly motivated Medical Device Engineer with strong experience in the design and development of complex catheter-based medical devices. This role is intended for candidates at the Engineer II through Senior Engineer level who are comfortable working hands-on, driving technical development activities, and contributing throughout the full product lifecycle from concept through commercialization. The ideal candidate will possess deep technical knowledge of catheter design, materials, and manufacturing processes, along with the ability to collaborate cross-functionally within a fast-paced medical device development environment. This position requires a strong balance of engineering fundamentals, hands-on prototyping capability, design control knowledge, and practical manufacturing understanding. Duties and Responsibilities • Participate in and/or lead the design and development of complex catheter-based medical devices and delivery systems, • Develop innovative design concepts and translate product requirements into functional engineering solutions, • Create detailed 3D CAD models, engineering drawings, assemblies, and technical specifications using SolidWorks or equivalent CAD platforms, • Perform engineering analysis including tolerance stack-ups, material selection, mechanical characterization, and performance evaluations, • Build, refine, and troubleshoot prototype devices through hands-on bench development and iterative testing, • Lead or support design verification activities including DV planning, development of test methods, protocol generation, and execution of mechanical and simulated-use testing, • Collaborate with Operations, Tooling, Quality, and Manufacturing Engineering teams to develop robust and scalable manufacturing processes, • Support Design for Manufacturability (DFM) initiatives related to catheter assembly, braiding, bonding, thermoforming, laser processing, and other specialized manufacturing techniques, • Prepare and maintain Design History File (DHF) documentation including design inputs, design outputs, risk management files, protocols, reports, and engineering change documentation, • Translate user needs, physician feedback, and clinical requirements into actionable engineering design inputs and specifications, • Participate in design reviews, technical discussions, and project planning activities to support program milestones and deliverables, • Support root cause investigations, CAPA activities, and product/process improvement initiatives, • Ensure compliance with applicable FDA regulations, ISO standards, and Aptyx Quality System requirements, • Mentor junior engineers and provide technical guidance where applicable, • Perform other duties as assigned in support of engineering and business objectives Required Qualifications • Bachelor's or Master's degree in Biomedical Engineering, Mechanical Engineering, or related engineering discipline, • Minimum of 3 years of medical device product development experience; 5+ years preferred, • Strong experience in the design and development of complex catheter systems, including one or more of the following:, • Multi-material composite catheter construction, • Multi-lumen shaft design, • Coil reinforcement structures, • Torque transfer systems including braids and laser-cut hypotubes, • Balloon integration and attachment methods, • Strong understanding of catheter materials including hypotubes, nitinol, polymer shafts, braids, coils, adhesives, and bonding processes, • Proficiency with 3D CAD software, preferably SolidWorks, • Demonstrated hands-on experience building prototypes, performing mechanical testing, and interpreting performance data, • Experience identifying and supporting appropriate catheter manufacturing processes and assembly methods, • Working knowledge of design controls, risk management, ISO 14971, ISO 13485, and 21 CFR Part 820, • Familiarity with applicable medical device standards including ISO 10555, ISO 11070, ISO 5840, ISO 25539, and related standards, • Strong analytical, problem-solving, and troubleshooting skills, • Effective verbal and written technical communication skills Preferred Qualifications • Experience with steerable or deflectable catheter systems, • Experience with complex multilumen shaft constructions or devices incorporating imaging, ablation, or therapeutic technologies, • Hands-on experience with catheter manufacturing processes including braiding, laser processing, bonding, reflow, tipping, and thermoforming, • Experience developing devices for structural heart, cardiovascular, or aortic applications, • Experience supporting transfer to manufacturing and production scale-up activities, • Familiarity with statistical analysis tools and engineering test method development Skills, Knowledge, and Abilities • Strong technical understanding of catheter design architecture and manufacturing methodologies, • Ability to work independently while managing multiple development priorities and timelines, • Strong documentation discipline and attention to detail within regulated environments, • Ability to collaborate effectively within cross-functional teams including R&D, Quality, Manufacturing, Regulatory, and Program Management, • Hands-on engineering mindset with strong troubleshooting and iterative development capability, • Ability to communicate complex technical concepts clearly to both technical and non-technical audiences Physical Demands and Work Environment This position requires work within office, laboratory, manufacturing, and cleanroom environments. The employee must be able to: • Sit, stand, and move throughout engineering labs and manufacturing areas, • Perform detailed hands-on prototype assembly and bench testing activities, • Use hands and fingers for fine motor assembly and measurement tasks, • Operate laboratory and test equipment safely and effectively, • Lift and move materials and equipment within safe working limits, • Communicate effectively both verbally and in writing Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions. Measurement of Performance • Achievement of project milestones and technical deliverables within established timelines, • Quality, completeness, and compliance of engineering and DHF documentation, • Effectiveness of prototype development, testing, and technical problem solving, • Contribution to successful product development and commercialization activities, • Collaboration and responsiveness within cross-functional project teams, • Compliance with regulatory, quality, and design control requirements, • Contribution to process improvements, innovation, and technical excellence within the engineering organization 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
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