Cardiac Catheter Development Engineer
Core
Design, prototype, and validate minimally invasive cardiac catheter devices and imaging algorithms for cardiovascular intervention research.
Role type
Senior IC medical device development engineer (cardiac catheters)
Builds
Next-generation catheter systems, guidewires, and accessory electronics for NHLBI research
Domain
Medical device engineering / Cardiovascular intervention
Deliverable
production ML models | product features
Required skills
CAD design (SolidWorks), catheter component design (shafts, tips, steering), sensor integration, electronic component integration, prototype fabrication, validation protocol execution, regulatory standards knowledge (ISO 10555, IEC 60601-1, ASTM), data analysis for regulatory submissions, design history file generation, FMEA, hazard analysis, biocompatibility matrix creation
Preferred skills
Mechanical and electrical test equipment operation, flow loops, simulated-use rigs, material science knowledge, Electrophysiology (EP) ablation catheter development, 510(k)/PMA/MDR submission experience, clean-room assembly, micro-fabrication
Technologies
SolidWorks, ISO 13485, ISO 10555, IEC 60601-1, ASTM standards
Responsibilities
Support engineering R&D for next-generation catheter systems; Design catheter components using advanced materials; Integrate complex electronic components into medical devices; Lead prototype fabrication ensuring ISO 13485 compliance; Develop and execute validation protocols aligned with regulatory standards; Conduct data analysis and prepare reports for regulatory submissions; Generate and maintain design history files, FMEAs, hazard analyses, and biocompatibility matrices
Seniority
Senior, hands-on IC