Aditi Dixit

Analyzed the FDA MAUDE database to identify device risks for intracardiac echocardiography (ICE) catheters, supporting risk management activities. Executed validation of catheter impedance test methods in compliance with internal and regulatory requirements. Conducted incoming inspections, prepared FAI reports and CoCs, and performed electrical safety testing per IEC 60601-2-37. Supported DV testing and managed equipment calibration records for lab and production systems.

Performed pulse-echo, impedance, and electrical testing of ICE catheters to ensure reliability. Designed phantoms and executed compliance testing (IEC 60601) for FDA 510(k) submissions. Developed and executed test plans for image quality and array temperature validation. Documented results in ALM Matrix QMS and collaborated with cross-functional R&D teams. Supported EMC testing