Teams at Capstan Medical

Own hardware verification and validation testing for a novel medical robotic platform. Develop test plans, methods, protocols, acceptance criteria, fixtures, and reports supporting FDA submissions. Lead reliability and mechanical testing against IEC 60601-1, coordinate external test houses, collaborate with manufacturing, investigate failures, and document results. The role requires mechanical engineering expertise, regulated medical device experience, CAD and GD&T proficiency, hands-on prototyping, sensing equipment familiarity, and strong technical writing.

Develop and deploy machine learning perception and controls systems for a cardiac surgical robot. Build image-to-robot registration, pose estimation, sensor-fusion, data, simulation, and evaluation pipelines using fluoroscopy and echocardiography. Collaborate with robotics, controls, clinical, and physician teams to improve device models and controllers. Deploy real-time models on robotic systems and produce validation and design documentation for FDA design controls.

Lead productization of robotic subsystems from engineering builds through clinical production. Develop and qualify manufacturing processes, fixtures, tooling, documentation, line layouts, and process controls for complex electro-mechanical surgical robots. Drive DFM/DFA, risk management, validation, root-cause investigations, supplier decisions, traceability, and cross-functional issue resolution while mentoring engineers and technicians.