Robert Frazier

Senior Systems Engineer at EarliTec Diagnostics Inc.
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Contact Information
us****@****om
(386) 825-5501
Location
Canton, Georgia, United States, GE
Skills

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Bio

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Credentials

  • CQE
    ASQ
    Dec, 2014
    - Oct, 2024

Experience

  • EarliTec Diagnostics Inc.
    • United States
    • Medical Equipment Manufacturing
    • 1 - 100 Employee
    • Senior Systems Engineer
      • Oct 2021 - Present

    • Principal Quality Engineer
      • Mar 2020 - Jun 2022

  • Children's Healthcare of Atlanta
    • United States
    • Hospitals and Health Care
    • 200 - 300 Employee
    • Lead Quality Engineer
      • Mar 2017 - Feb 2020

    • Quality Engineer
      • Oct 2016 - Mar 2017

  • St. Jude Medical
    • United States
    • Medical Equipment Manufacturing
    • 700 & Above Employee
    • Quality Assurance Engineer
      • Mar 2015 - Sep 2016
  • Terumo Cardiovascular Systems
    • United States
    • Medical Equipment Manufacturing
    • 1 - 100 Employee
    • Design Quality Assurance Engineer II
      • Oct 2012 - Nov 2014

      Created, released, and maintained Risk Management files to support primary product line. Subject matter expert for Risk Management System, as well as procedural and FDA requirements. As primary Design Quality Assurance Engineer, ensured product changes did not impact risk profile and were completed with appropriate level of quality. Created, released, and maintained Risk Management files to support primary product line. Subject matter expert for Risk Management System, as well as procedural and FDA requirements. As primary Design Quality Assurance Engineer, ensured product changes did not impact risk profile and were completed with appropriate level of quality.

  • Boston Scientific
    • United States
    • Medical Equipment Manufacturing
    • 700 & Above Employee
    • R&D Engineeer
      • Nov 2009 - Oct 2012

      Sustaining R&D Engineer and technical lead for Urological products. Led teams in product changes and product related CAPAs from concept and development through verification/validation and release. Subject matter expert for design change process and design control. Sustaining R&D Engineer and technical lead for Urological products. Led teams in product changes and product related CAPAs from concept and development through verification/validation and release. Subject matter expert for design change process and design control.

    • Process Development Engineering Co-op
      • 2006 - 2009

      Rotational engineering co-op/intern supporting process development for Endoscopic products. Performed prototype and validation testing and wrote subsequent reports. Analyzed Process FMEAs to confirm consistency with respective Design FMEAs. Performed DOE and identified optimal process limits for critical product features. Rotational engineering co-op/intern supporting process development for Endoscopic products. Performed prototype and validation testing and wrote subsequent reports. Analyzed Process FMEAs to confirm consistency with respective Design FMEAs. Performed DOE and identified optimal process limits for critical product features.

Education

  • University of Toledo
    Bachelor of Sciences, BioEngineering
    2004 - 2009

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