Tom Huber

Medical Device Product Development

Orlando, Florida, United States

About

• 9 years in design and commercialization of implanted medical devices and surgical instruments. • Well versed in ISO 13485, ISO 14971, FDA 510(k) and 21 CFR 820, European MDD/MDR. • Breadth of manufacturing knowledge spans subtractive, additive and injection molded components.

Experience

  • Senior Product Development Engineer at Xēnix Medical
    Aug 2022 - Present · 3 yrs 11 mos

  • Senior Product Development Engineer at Optimotion Implants
    Feb 2021 - Jul 2022 · 1 yr 6 mos

    Plan and drive product realization efforts from concept to commercialization.

  • Product Development Engineer at Genicon, Inc.
    Aug 2019 - Sep 2020 · 1 yr 2 mos

    Design and development of surgical instruments for use in endoscopic procedures.

  • Manufacturing Engineer at Parcus Medical
    Jun 2016 - Jul 2019 · 3 yrs 2 mos

    Design and development of orthopedic implants and surgical instruments for use in arthroscopic procedures.

  • Mechanical Engineer at Polypack, Inc.
    Jun 2014 - Jun 2016 · 2 yrs 1 mo

    Design of custom machinery for the automation of product handling, pad forming, and shelf-packaging.