Jeff Berger

VP Engineering & Quality at SteriCUBE
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Contact Information
us****@****om
(386) 825-5501
Location
Naples, Florida, United States, US

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Experience

    • United States
    • Medical Equipment Manufacturing
    • 1 - 100 Employee
    • VP Engineering & Quality
      • Jul 2022 - Present

      Florida, United States Maintains the Quality Management System and Class II medical device production in compliance with FDA 21CFR820 and ISO 13485:2016. Oversees development, engineering, and manufacturing functions to incorporate innovative solutions and realize top product performance.

    • United States
    • Wholesale Building Materials
    • 1 - 100 Employee
    • Director of Engineering
      • Jan 2022 - Jul 2022

      Pinellas Park, Florida, United States Independently designed and certified Glassworks’ high-flow SOFAs for VGBA 2017, ANSI/APSP/ICC-16 2017, NSF/ANSI/CAN 50 - 2020, and BS EN 13451-1:2020. Commissioned injection mold tooling and compliant part sourcing. Created Quality Management System to support certified products and engineering submittal package for all Glassworks' products.

    • United States
    • Recreational Facilities
    • 1 - 100 Employee
    • Principal - Engineering & Operations
      • Nov 2019 - Dec 2021

      Naples, Florida, United States Designed new products and improved current product line for commercial water parks, lazy rivers, and competition pools. Responsible for engineering, international supply chain (including reshoring), manufacturing, quality assurance, and training. Provided engineering consulting services including single-phase and multi-phase computation fluid dynamic (CFD) analyses.

    • United States
    • Hospitals and Health Care
    • 700 & Above Employee
    • Executive Director - Sterile Processing & Distribution
      • Nov 2018 - Nov 2019

      Fort Myers, Florida, United States Led the transformation of system-wide sterile processing for surgical operations that achieved DNV-GL’s SPPC certification (1st in Florida and 1st offsite reprocessing center in the USA). Developed and implemented a Quality Management System for sterile processing and facilitated the formation of a cross-sectional team to oversee operations that included front-line techs, nurses, administrators, and surgeons.

    • Lean Transformation Specialist
      • Dec 2016 - Feb 2019

      Fort Myers, Florida, United States Served as an internal consultant and project manager to facilitate the transformation of Lee Health systems and development of people by applying principles, critical thinking, and scientific problem solving. Focused on surgical services, sterile processing, and operating system development.

    • Rail Transportation
    • 700 & Above Employee
    • Asst. Plant Manager
      • Jul 2015 - Dec 2016

      Conway, PA Responsible for the safe and efficient operations of the Conway Locomotive Shop and surrounding territory.

    • Regional Operations Manager
      • Aug 2013 - Jun 2015

      Elkhart, IN Responsible for all mechanical operations of the Elkhart Terminal and line-of-road territory between Chicago and Toledo.

    • Regional Operations Manager
      • Mar 2011 - Jul 2013

      Allentown, PA Responsible for all mechanical operations of the Allentown Terminal serving greater Philadelphia, New Jersey, and Wilkes-Barre/Scranton.

    • Manager – Car Data and Performance
      • Jun 2009 - Mar 2011

      Atlanta, GA Managed projects and applied data insights to develop system-wide technical standards and policy. Responsible for department data governance, reporting, and analysis. Served on AAR CRB Committee and Job Code Time Study subcommittee.

    • Mechanical Operations Supervisor
      • Mar 2008 - Jun 2009

      Altoona, PA Supervised the Test Shed, Overhaul Line, and Backshop sections of the Juniata Locomotive Shop.

    • Mechanical Management Trainee
      • Jan 2007 - Feb 2008

Education

  • Penn State University
    Bachelor of Science Mechanical Engineering
  • Brenau University
    Master of Business Administration (MBA), Management
  • University of Kentucky
    Lean Production Systems Certificate

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