Catheter R&D Engineer

Aptyx•Olympic Woods, NC

12d•Onsite

About The Position

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.

Requirements

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

Nice To Haves

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

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