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Dr Natalie James is a seasoned biomedical engineer with extensive experience in medical device development, regulatory affairs, and research. She has worked on various projects, including the development of Class III implantable biventricular assist devices and Class IIb sperm separation devices. Her expertise spans biocompatibility, biological risk analysis, and design of verification and validation test plans. She holds a PhD in Biomedical Engineering from the University of New South Wales and a Graduate Diploma in Management from Macquarie University. Dr James is currently based in the Greater Sydney Area.

Experience

  • CardioBionic
    • Sydney, New South Wales, Australia
    • Biology & Materials, Regulatory & Clinical Operations
      • Feb 2022 - Present
      • Sydney, New South Wales, Australia

      Cardiobionic is developing Class III implantable biventricular assist devices targeted to the low-cost market (eg. India). These are next-generation devices based on the rotary blood pump developed by Ventracor (see below). My responsibilities have included: carbon coating development; materials ...

  • Memphasys Ltd
    • Sydney, Australia
    • Design and Development
      • May 2020 - Present
      • Sydney, Australia

      Memphasys Ltd has developed a Class IIb sperm separation device to fractionate sperm from a human semen sample, for use in Intracytoplasmic Sperm Injection (ICSI), which is commonly used in in vitro fertilisation (IVF). This technology uses electrophoresis and a number of membranes in the sperm s...

    • Australia
    • Higher Education
    • 700 & Above Employee
    • Senior Visiting Fellow
      • Jan 2020 - Present

    • Associate Professor, Graduate School of Biomedical Engineering
      • Jul 2017 - Dec 2019

      The Tyree Foundation Institute of Health Engineering (IHealthE) was proposed as a new Institute at UNSW for the growth and rapid translation of clinical and biomedical engineering research to commercial technologies and/or clinical practice. My role was to work with the newly appointed Director, Prof Nigel Lovell, to prepare the business case to launch the institute and drive operations.

    • Project Manager, Graduate School of Biomedical Engineering
      • Sep 2013 - Jun 2017

      Project management of the Bionic Vision Australia Wide View 99 channel vision prosthesis under development in the Graduate School of Biomedical Engineering, including research and product development phases. This role encompassed milestone-driven oversight of verification and validation testing, including biocompatibility, preclinical trials and human cadaver surgical and device fit studies.

    • Adjunct Senior Lecturer
      • Dec 2012 - Dec 2015

    • Clinical Manager
      • Oct 2016 - Present
      • Sydney, Australia

      The Brain Protection Company is developing a Class III implantable cardiovascular device for protection against dementia. My responsibilities: biocompatibility assessment, including management of preclinical implant trials in sheep; interpretation of medical literature to support a range of requi...

  • Griffith University
    • Queensland Micro and Nano Technology Centre
    • Board Member
      • May 2012 - Present
      • Queensland Micro and Nano Technology Centre
    • Grant Proposal & Writing Consultant
      • Oct 2009 - Jul 2023
    • Co-Founder and Operations Director
      • Sep 2013 - Sep 2016

      Sky Biomed was an Australian biomedical device company for development of devices for urinary continence management.

  • University of Sydney
    • School of Physics
    • Honorary Associate
      • Mar 2004 - Dec 2015
      • School of Physics
  • CreateRx
    • Sydney, Australia
    • Co-Founder and Director
      • Mar 2013 - Sep 2013
      • Sydney, Australia
    • Principal Research Engineer
      • Apr 2008 - Aug 2012

      Cochlear is an Australian medical device company which is the global leader in technologies that enable hearing in the profoundly deaf. F12 revenue $779M, with > 2,200 employees globally.• Obtained funding and implemented research projects as named investigator on collaborative CSIRO Science a...

  • Ventracor Ltd
    • Sydney, Australia
    • Applied Research Manager
      • Feb 1998 - Feb 2008
      • Sydney, Australia

      Ventracor was an Australian medical device company which developed an innovative implantable ventricular assist device. This heart support system received market approval in Europe (CE Mark) and Australia (TGA approval) and IDE trials were completed in the US; in excess of 450 patients were suppo...

Education

  • Macquarie University
  • 1990 - 1993
    University of New South Wales
  • 1985 - 1989
    University of New South Wales
  • 1981 - 1984
    University of Sydney
  • UNSW

Suggested Services

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Industry Focus. “Medical Equipment Manufacturing”

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