Hilary Soohoo
About Hilary Soohoo
Hilary Soohoo is a Product Manager and Systems Engineer at Cleerly, Inc in the Greater New York City Area, with extensive experience in healthcare design and regulatory compliance.
Company
Hilary Soohoo is currently employed at Cleerly, Inc in the Greater New York City Area. At Cleerly, Inc, she holds the position of Product Manager & Systems Engineer, where she manages a cross-functional team and oversees the development and regulatory clearance of medical devices.
Education and Expertise
Hilary Soohoo completed her Master of Engineering (MEng) in Systems Engineering from Cornell University in 2017. Prior to that, she earned a Bachelor of Science (B.S.) in Nutrition Sciences from Cornell University in 2013. Her education laid a strong foundation for her career in systems engineering and product management. She has extensive knowledge of ISO 13485, IEC 14971, IEC 62366, IEC 62304, and AAMI TIR 45 standards.
Professional Background
Before her current role at Cleerly, Inc, Hilary Soohoo worked in various positions at Cornell University and Weill Cornell Medicine. She served as a Systems Engineer for multiple projects, including the Healthcare Design Project and Six Sigma BlackBelt Certification Project. She also worked as a Program Specialist and Research Assistant in the Dalio Institute of Cardiovascular Imaging, Department of Radiology at Weill Cornell Medicine. Her earlier roles included positions at Cornell University's Autonomous Underwater Vehicle Team and as an Honors Undergraduate Researcher.
Key Achievements
During her tenure at Cleerly, Inc, Hilary Soohoo led the company to secure two FDA 510k clearances for a machine learning medical device. She directed a team of 12 professionals through a phase-gate approach to achieve these clearances. She has authored the 510k application and managed all correspondence with the FDA, supervised the creation of over 100 regulatory-compliant product documents, and actively maintained the Design History File (DHF) through design control processes.