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Olivia Tran

2nd

Previous positions

  • Sr. Systems Engineer IV at Grifols
  • Sr. Systems Engineer IV at Hologic (Formerly Gen-Probe)

Education

University of California San Diego, BS, Bioengineering-Biotechnology

500+

Background

Summary

Experienced Systems Engineering Manager with a demonstrated history of working in the biotechnology industry. Skilled in Verification and Validation (V&V), Medical Devices, SolidWorks, LabVIEW, and Biotechnology. Strong engineering professional with a Certification focused in System Engineering from UCLA.

Experience

  • Supervisor, Software Systems Engineering

    Illumina

    July 2018 – Present(1 year 3 months)San Diego, California

  • Sr. Software Systems Engineer

    Illumina

    January 2018 – Present(1 year 9 months)Greater San Diego Area

  • Sr. Systems Engineer IV

    Grifols

    October 2016 – December 2017(1 year 2 months)Greater San Diego Area

    Facilitated the technical transition of the Blood Screening business from Hologic to Grifols. Lead engineer at San Diego site supporting instrument platform development/sustaining, assay development and product software management. Supported Regulatory Affairs in 510(k) submissions with system level design control definition.

  • Sr. Systems Engineer IV

    Hologic (Formerly Gen-Probe)

    June 2010 – October 2016(6 years 4 months)Greater San Diego Area

    Deliver strategy for system level validation, product and process level risk management. Lead engineering core team rep for design, development, implementation, commercialization and sustaining instrument platforms for molecular diagnostic testing. Build cross functional understanding among QA, RA, SW/HW development and program management) regarding assay development and instrument integration requirements.

  • Manager of Product Development

    Applied Medical

    November 2006 – June 2010(3 years 7 months)

    Led team of experienced plastic injection molding designers, mechanical engineers and process development engineers in end to end development of complex, energy-driven medical devices. Successful implementation of two mechanically driven medical devices from design through packaged product.

  • Research Associate

    Dexcom

    June 2005 – November 2006(1 year 5 months)

    Continuous glucose monitoring sensor development. Focused on materials, application and technology development.

Education

Skills & Expertise

  • Engineering
  • Design Control
  • ISO 14971
  • Cross-functional Team Leadership
  • Team Management
  • Automation
  • Design for Manufacturing
  • Production Process Development
  • Solidworks
  • ISO 13485
  • Electronic System Design
  • Product Launch
  • Biomaterials
  • Validation
  • Labview
  • Minitab
  • Manufacturing
  • Biomedical Engineering
  • Systems Engineering
  • SolidWorks
  • Research and Development (R&D)
  • CAPA
  • Good Manufacturing Practice (GMP)
  • Process Simulation
  • Quality System
  • Product Management
  • Risk Management
  • FDA
  • Embedded Systems
  • Biotechnology
  • Medical Devices
  • Consumables
  • R&D
  • Software Testing
  • Software Systems Engineering
  • Design of Experiments
  • Software Project Management
  • Technology Development
  • Software Development Life Cycle (SDLC)
  • V&V
  • U.S. Food and Drug Administration (FDA)
  • Product Development
  • Unified Modeling Language (UML)
  • Commercialization
  • Six Sigma
  • Testing
  • Contract Management

Certifications

  • UCLA- System Engineering Certification

    , License
  • Certified Tester Foundation Level (CTFL)

    ASTQB – Official Page – American Software Testing Qualifications Board, License