Alfred Pon

Hardware Engineering Lead at Vorum
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Contact Information
us****@****om
(386) 825-5501
Location
Vancouver, British Columbia, Canada, CA
Skills

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Credentials

  • P.Eng.
    Association of Professional Engineers and Geoscientists of British Columbia
    Dec, 1991
    - Oct, 2024

Experience

  • Vorum
    • Canada
    • Software Development
    • 1 - 100 Employee
    • Hardware Engineering Lead
      • Sep 2022 - Present

      - Collaborate with internal stakeholders and vendors to develop a 3D printing solution.- Manage an industrial design contractor to develop a 3D scanner housing for a tablet PC.- Setup an agreement with a manufacturer in China to produce 3D scanner products in high volumes.- Lead investigations into product quality issues.- Validate drivers and installer programs for 3D scanner products.

    • Hardware Production Engineer / Regulatory Affairs Specialist
      • May 2020 - Aug 2022

      - Transfer new product design features and changes to production.- Produce medical device registration roadmaps for 3D scanner products in various international markets.- Provide guidance for medical device registration of 3D scanner product for cranial remolding orthosis in China. - Manage a team to conduct a gap analysis and update elements of QMS to improve ISO 13485:2016 readiness.- Fill out IT security questionnaires to support Sales team during pre-Sales assessement to meet HIPAA requirements. Show less

    • Manufacturing & Regulatory Lead
      • Jan 2017 - Apr 2020

      - Source and test replacement part for end of life components.- Investigate solutions to improve manufacturability and scalability of products.- Execute work orders of subassemblies and incoming inspection of critical parts.- Outsource 3D scanner product to contract manufacturer.- Implement FDA cGMP and ISO 13485 Quality Management System to support a Class 2 medical device and 510K cranial remolding orthosis application. - Advise company on all regulatory compliance issues.

    • Product Engineer
      • Feb 1999 - Dec 2016

      - Lead Engineer for the product design, manufacturing, Quality Assurance, and installation of 3D laser scanners used for fabrication of cranial remolding orthosis.- Provide Technical Support for international customer base of 3D laser scanner hardware and software products.- Performs hardware and software testing & validation for company's suite of CAD/CAM products.- Execute QA testing in manufacturing to ensure delivery of quality product.- Repair and maintain 3D scanning products. Show less

  • International Telepresence Corporation
    • Systems Engineer
      • Mar 1997 - Feb 1999
  • McKesson Health Solutions (ALI Technologies)
    • Systems Engineer
      • Feb 1996 - Mar 1997
  • Xillix Technologies
    • Medical Equipment Manufacturing
    • Research and Development Engineer
      • May 1989 - Feb 1996

Education

  • The University of British Columbia
    Bachelor of Applied Science (B.A.Sc.), Electrical and Electronics Engineering
    1983 - 1989

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