Gokce (Gilly) Yildirim

CEO at Vent Creativity
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Experience

    • United States
    • Medical Equipment Manufacturing
    • 1 - 100 Employee
    • CEO
      • Apr 2020 - Present

      Vent Creativity pioneers digital twin technologies for surgical planning. Our patented AI platform is appropriate for research and implant design testing, and will soon be clinically available for all surgical planning philosophies, starting with total and partial knee plans. Vent Creativity pioneers digital twin technologies for surgical planning. Our patented AI platform is appropriate for research and implant design testing, and will soon be clinically available for all surgical planning philosophies, starting with total and partial knee plans.

    • United States
    • Medical Device
    • 1 - 100 Employee
    • Head of Business Development and Client Services
      • Nov 2021 - Nov 2022

      Consulting C-level medical device leaders for regulatory and business strategy needsIdentifying new target companies to engage and assist for their needs

    • Sr. Project Coordinator & Accounts Manager
      • Oct 2020 - Nov 2021

      Medical device regulatory and product roadmap strategy consulting.Wide portfolio of medical devices covered from EUA submissions to Class III and combination devices.

    • United States
    • Biotechnology Research
    • 1 - 100 Employee
    • Sr. Staff Product Development Engineer
      • Oct 2019 - Oct 2020

      Engineering leadership for the first ever regulated work towards 3d printed biologics product development. IND path orphan drug status. Early response to Covid-19 with a NIOSH approved PAPR equipment production for the healthcare professionals to protect themselves from the virus. Engineering leadership for the first ever regulated work towards 3d printed biologics product development. IND path orphan drug status. Early response to Covid-19 with a NIOSH approved PAPR equipment production for the healthcare professionals to protect themselves from the virus.

    • United States
    • Medical Equipment Manufacturing
    • 700 & Above Employee
    • Senior Staff Product Development Engineer
      • Mar 2018 - Sep 2019

      CT based bone density prediction platform, experimental implant evaluation validation, financial models for pull-through revenue prediction, project feasibility assessment and management

    • Staff Product Development Engineer
      • Oct 2013 - Feb 2018

      Internal consultancy, financial, marketing, and product development feasibility assessment. Cross-functional project team management

    • Research Engineer
      • Sep 2011 - Oct 2013

      Research and development of first ever additive manufactured titanium implant in the USA. Regulatory filing of New Era Orthopedics (NEO) and MAKO inplants through the FDA 510(k) clearance process. Manufacturability of laser sintered additive manufactured products for medical applications. ASTM standard authorship for medical device testing protocols. Research and development of first ever additive manufactured titanium implant in the USA. Regulatory filing of New Era Orthopedics (NEO) and MAKO inplants through the FDA 510(k) clearance process. Manufacturability of laser sintered additive manufactured products for medical applications. ASTM standard authorship for medical device testing protocols.

    • United States
    • Hospitals and Health Care
    • 300 - 400 Employee
    • R&D Engineer
      • Aug 2004 - Sep 2011

      Peter Walker Minimally Invasive Surgery Lab. Design and manufacturing of electronics and hardware of PLC driven test machines for medical device testing Concept development of orthopaedic devices which led to implant lines such as Persona Knee (Zimmer) MAKO triconpartmental knee testing Leadership of junior engineers, surgeons, and resident in various cadaveric studies for peer reviewed publications Peter Walker Minimally Invasive Surgery Lab. Design and manufacturing of electronics and hardware of PLC driven test machines for medical device testing Concept development of orthopaedic devices which led to implant lines such as Persona Knee (Zimmer) MAKO triconpartmental knee testing Leadership of junior engineers, surgeons, and resident in various cadaveric studies for peer reviewed publications

Education

  • Columbia University - Columbia Business School
    Master of Business Administration (MBA), Entrepreneurship/Entrepreneurial Studies
    2017 - 2019
  • Columbia Engineering
    MS, Biomedical Engineering
    2003 - 2004
  • New Jersey Institute of Technology
    B.S., Industrial Engineering
    1999 - 2003
  • The Leys School
    high school, A-levels in maths, physics, business studies, GCSEs
    1994 - 1999

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