Hilary Soohoo Gambardella
Systems Engineer Lead @Hologic, Inc.
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WORK HISTORY
Systems Engineer Lead @Hologic, Inc.
EDUCATION
Cornell University
Bachelor of Science (B.S.), Nutrition Sciences
New Canaan High School
HS Diploma, General Studies
Cornell University
Master of Engineering (MEng), Systems Engineering
SKILLS
ABOUT HILARY SOOHOO GAMBARDELLA
Experienced Systems Engineer with a demonstrated history of developing software-only ML products in the medical device industry. Proficient in all product development phases of planning, risk-based product development, software integration, and verification and validation. Expert in requirements definition, analysis, and traceability, as well as development of FDA compliant product documentation (functional/business requirements, hazard analysis, verification test protocols/reports, usability protocols/reports, substantial equivalence protocols/reports). Skilled in managing cross-functional teams to realize regulatory-compliant products and build product consensus among UI/UX, software engineering, clinical, regulatory, quality departments. Six Sigma Black Belt with a Masters of Engineering (MEng) in Systems Engineering from Cornell University.
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