Kit Yee Au-Yeung

General Manager at SandboxAQ
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Contact Information
us****@****om
(386) 825-5501
Location
San Francisco, California, United States, US
Languages
  • English Native or bilingual proficiency
  • Mandarin Native or bilingual proficiency
  • Cantonese Native or bilingual proficiency

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5.0

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Marcie Hamilton

Kit leads the product team at Profusa. She synthesizes use cases and design inputs to create a product roadmap with the right device attributes and features. In order to successfully launch products, Kit: conducts customer interviews, manages user testing, allocates resources, performs market assessments, and translates business-to-technical requirements. She is also very strong cross-functionally. Kit develops regulatory approval pathways and leads teams through successful regulatory agency meetings and approval. On top of all of this, she is successful at planning for and running notified body audits and working closely at all times with quality affairs. With respect to clinical, Kit: writes protocols with thoughtful endpoints, obtains approval to run studies in various geographic locations, and launches and facilitates studies. She is great presenter due to her personal style and substance. Kit is a multi-talented and driven boss, mentor, and co-worker. I miss her collaborating with her!

Hooman Hafezi

Kit has a terrific combination of technical and management skills. We worked together on many projects for ~6 years, and she was consistently driven, energetic, and capable of leading teams and driving critical projects to completion under pressure and with limited resources. She also has a great ability to focus on the essential aspects of a problem and to communicate well and collaborate across functional disciplines (engineering, production, clinical, regulatory, business development).

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Experience

    • United States
    • Software Development
    • 100 - 200 Employee
    • General Manager
      • Jan 2022 - Present

      SandboxAQ is an enterprise SaaS company combining AI + Quantum tech to solve hard problems impacting society. I focus on Life Sciences & Healthcare, leading a team to catalyze a new generation of medical diagnostic devices. SandboxAQ is an enterprise SaaS company combining AI + Quantum tech to solve hard problems impacting society. I focus on Life Sciences & Healthcare, leading a team to catalyze a new generation of medical diagnostic devices.

    • United States
    • Holding Companies
    • 500 - 600 Employee
    • Product Manager
      • Mar 2021 - Jan 2022

      Bringing physics + AI based technology to life! Bringing physics + AI based technology to life!

    • United States
    • Research
    • 400 - 500 Employee
    • Product Manager
      • Jul 2018 - Mar 2021

      As a product lead on an early stage mental health project, I conducted extensive user research to define consumer & clinician products that enable monitoring & prediction of depression and anxiety among young adults. As a product lead on an early stage mental health project, I conducted extensive user research to define consumer & clinician products that enable monitoring & prediction of depression and anxiety among young adults.

    • United States
    • Medical Equipment Manufacturing
    • 1 - 100 Employee
    • Vice President, Product
      • Jul 2015 - Jun 2018

      • Led a team to develop Profusa’s first product in 14 months, secured ISO 13485 certificate and CE-mark (93/42 MDD) six months later • Set up a clinical registry study using CE-marked product at three European locations • Collaborated with Quality and Engineering to iterate product based on customer feedback and field observations • Collaborated with Clinical and Data Scientists to explore new product value propositions • Negotiated a biological risk assessment program with the… Show more • Led a team to develop Profusa’s first product in 14 months, secured ISO 13485 certificate and CE-mark (93/42 MDD) six months later • Set up a clinical registry study using CE-marked product at three European locations • Collaborated with Quality and Engineering to iterate product based on customer feedback and field observations • Collaborated with Clinical and Data Scientists to explore new product value propositions • Negotiated a biological risk assessment program with the FDA, and led the program to completion • Led a team to prepare the company’s first US FDA de novo application

    • Director of Product & Market Development
      • Feb 2013 - Jul 2015

      • Took the company’s novel oxygen sensing technology from pre-clinical proof-of-concept to first-in-human feasibility study in eight months • Co-authored a peer-reviewed publication that reported study results • Planned and attended FDA meetings to define regulatory pathway • Created a product development roadmap for commercialization

    • United States
    • Pharmaceutical Manufacturing
    • 1 - 100 Employee
    • Manager, Development Programs
      • Sep 2011 - Jan 2013

      • Led an initiative on improving tuberculosis (TB) case management in China • Secured a grant award from a major global NGO to support the program • Formulated clinical and regulatory plans for the conduct of human studies to support market registration; prepared submissions to China SFDA • Coordinated product development effort with a focus on improving TB case management • Interacted with clinicians, nurses, and patients in the US and China to understand product design needs

    • Senior Clinical Scientist
      • Sep 2008 - Sep 2011

      • Designed and executed seven clinical studies aimed to characterize the safety and efficacy of a novel platform technology in therapeutic areas spanning TB, type 2 diabetes, cardiovascular diseases, and psychiatric illness • Collaborated with statisticians on endpoint analyses • Prepared clinical and regulatory submissions to IRBs, FDA, EC & notified bodies • Implemented corporate publication strategy; authored and presented peer-reviewed manuscripts and abstracts at conferences

    • Clinical Engineer
      • Jul 2006 - Sep 2008

      • Designed and executed pre-clinical and early clinical studies • Prepared clinical and regulatory submissions to IRBs and notified bodies • Participated in organizational development team

    • United States
    • Medical Equipment Manufacturing
    • 700 & Above Employee
    • Intern, Cardiac surgery divsion
      • Mar 2006 - Apr 2006

    • United States
    • Medical Equipment Manufacturing
    • 100 - 200 Employee
    • Intern, Hardware design devision
      • Jun 2001 - Aug 2001

Education

  • Duke University
    PhD, Biomedical Engineering
  • Stanford University Graduate School of Business
    Certificate in Innovative Product Leadership: The Emerging Chief Product Officer, Business Administration, Management and Operations
    2022 - 2022
  • MIT xPRO
    Certificate in Quantum Computing Fundamentals, Quantum Computing
    2022 - 2022
  • Harvard Business School Online
    Certificate of Specialization: Strategy, (Health Care Economics, Disruptive Strategy, Strategy Execution)
    2021 - 2022
  • Stanford University
    Post-doctoral Fellowship, Biodesign
    2005 - 2006
  • University of California, San Francisco
    Department of Epidemiology and Biostatistics
  • Duke University
    BSE, Magna Cum Laude, Biomedical Engineering

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