Harry Ai
Product Development Manager @Outset Medical, Inc.
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WORK HISTORY
Product Development Manager @Outset Medical, Inc.
San Francisco, CA, US
Lead the development and iterative improvement of new medical devices (Tablo® hemodialysis systems), from concept design to validation testing, regulatory registration, and commercialization. Responsible for the overall planning, resource allocation, and execution of R&D projects, ensuring schedule, budget, and quality targets are met. Collaborate with cross-functional teams (systems, hardware,
EDUCATION
Case Western Reserve University
M.S
ABOUT HARRY AI
I work in medical device R&D with a focus on product development and cross functional team collaboration. My experience includes leading projects from concept through system integration, validation, regulatory approval, and commercialization, including the Tablo® hemodialysis system. I’m also familiar with FDA and ISO requirements, ensuring projects move forward efficiently and in compliance.
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