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Benjamin Lee is a seasoned biomedical engineer with expertise in clinical development, software development, and research. He has led teams in developing innovative medical devices and tissue-engineered blood vessels. Lee holds a Ph.D. in Bioengineering from UC Berkeley and certifications in Design Control Requirements and Human Factors for Medical Devices.

Credentials

  • Design Control Requirements and Industry Practice
    Association for the Advancement of Medical Instrumentation (AAMI)
    Apr, 2018
    - Apr, 2026
  • Human Factors for Medical Devices
    Association for the Advancement of Medical Instrumentation (AAMI)
    Jan, 2018
    - Apr, 2026
  • Abbott Structural Heart MitraClip Therapy Sales Training
    -

Experience

  • Telos Health
    • Campbell, California, United States
    • Principal Clinical Engineer
      • May 2023 - Present
      • Campbell, California, United States

    • United States
    • Medical Equipment Manufacturing
    • 700 & Above Employee
    • Sr. Clinical Development Engineer
      • Apr 2020 - Apr 2023

      -Apply in-depth knowledge of OR environment and clinical use to assess and document clinical requirements and risks-Collaborate closely with product management and product development to define, develop and validate clinical functions of next-gen and new products-Serve as clinical expert to lead training activities and provide procedural support to new and existing users

    • Clinical Development Engineer
      • Feb 2018 - Apr 2020

      Endoluminal division-Serve as clinical lead for all software-related (e.g. UX, systems) development activities-Lead execution of clinical labs using cadaveric and living porcine models-Define development and execution strategies for design (clinical) validation activities-Lead training and product demonstrations for internal teams (sales representatives, customer support), external customers, and regulatory bodies (FDA, CFDA)-Lead procedural support for multiple clinical and commercial sites-Collaborate with key opinion leaders (KOLs) and clinical specialists in pulmonology space to identify clinical needs and leverage clinical relevance

  • Abbott
    • Menlo Park, CA 94025
    • Senior Research And Development Engineer
      • Sep 2014 - Feb 2018
      • Menlo Park, CA 94025

      -Interfaced with key opinion leaders (KOLs) and clinical specialists to identify clinical needs and leverage clinical relevance for test method development and training material updates-Designed and executed formative usability studies to validate clinical safety and efficacy in order to provide guidance to design teams and support FDA/regulatory documentation and submission-Designed subsystem- and system-level engineering studies and standard test methods for improving process development, determining design requirements, and establishing product specifications-Defined development and execution strategies through design transfer for test method validation, design verification and validation activities, and human factors engineering testing-Supported training and product demonstrations for internal teams, external customers, and regulatory bodies-Improved existing and designed new tooling and fixtures using SolidWorks-Mentored and provided work direction to 1 technician and 1 associate engineer-Led design select and characterization testing involving coordination and collaboration with multiple material suppliers-Managed strategic planning of 14 technician resources for site-wide cross-functional activities and testing-Completed certification for Abbott Vascular's MitraClip Therapy Sales Training

    • United States
    • Higher Education
    • 700 & Above Employee
    • Ph.D. Candidate
      • Aug 2009 - Jun 2014

      -Led team in the development and fabrication of small-diameter bioactive nanofibrous vascular graft with stem cell homing potential for cardiovascular applications-Led team in the synthesis and development of in vivo tissue-engineered blood vessel substitute(“biotubes”) for autologous and xenogenic applications-Served as scientific consultant for stem cell, biomaterial, and tissue regeneration research performedby fellow colleagues-Identified new source of stem cells in synovial joint and investigated their interaction with electrospunscaffolds with varying topographical cues-Designed and fabricated porous electrospun scaffolds (via co-electrospun composite meshes,femtosecond laser ablation, micropatterned PDMS surfaces) for tissue engineering applications-Collaborated on the enhancement of biocompatibility and biological performance of plasma-treatedelectrospun scaffolds

    • Graduate Student Instructor
      • Aug 2010 - Dec 2010

      -Led multiple groups of undergraduate students in discussion of lecture material, journal club presentations, and exam review sessions-Instructed the entire class as substitute lecturer in the absence of the professor-Assisted and mentored students during weekly office hour on lecture material and career development

  • Abbott Vascular
    • Santa Clara
    • Research Analyst
      • Sep 2013 - Feb 2014
      • Santa Clara

      -Conducted detailed data and biostatistical analyses on results from preclinical studies for ongoing R&D of novel medical device to evaluate device efficacy and safety-Organized and presented results and analyses in weekly one-on-one and team meetings-Assisted in preparation and coordination of preclinical studies for device testing and evaluation

  • Northrop Grumman
    • Redondo Beach
    • Technical Intern
      • Jun 2011 - Aug 2011
      • Redondo Beach

      -Investigated the use of ultrasound and acoustic waves to generate field-induced forces for cell manipulation in controlled three-dimensional microenvironments for scaffold-free tissue engineering-Drafted standard operating procedures (SOPs) for laboratory equipment and experimental protocols and conducted comprehensive training to core team and staff-Set up biosafety level II tissue culture lab with essential laboratory equipment and instruments and performed regular calibration and maintenance for quality assurance

Education

  • University of California, Berkeley
    Bachelor of Science (B.S.), Bioengineering and Biomedical Engineering
  • University of California, Berkeley
    Doctor of Philosophy (Ph.D.), Bioengineering, with certification in Management of Technology

Suggested Services

This profile is unclaimed. These are suggested service rates with 0% commision upon successful connection

Industry Focus. “Biotechnology”

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