Bachelor's or Master's degree in Biomedical Engineering, Mechanical Engineering, or a related engineering discipline
Minimum of 3 years of medical device product development experience
Strong experience in the design and development of complex catheter systems, including multi-material composite catheter construction, multi-lumen shaft design, coil reinforcement structures, and torque transfer systems
Strong understanding of catheter materials including hypotubes, nitinol, polymer shafts, braids, coils, adhesives, and bonding processes
Proficiency with 3D CAD software
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 standards, and 21 CFR Part 820
Familiarity with applicable medical device standards including ISO 5840
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
The employee must be able to sit, stand, and move throughout engineering labs and manufacturing areas
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
