Joanna Fakhoury

Principal Product Development Engineer at Switchback Medical
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Contact Information
us****@****om
(386) 825-5501
Location
Minneapolis, Minnesota, United States, US
Languages
  • Spanish -

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Experience

    • United States
    • Medical Equipment Manufacturing
    • 1 - 100 Employee
    • Principal Product Development Engineer
      • Dec 2021 - Present

    • United States
    • Medical Equipment Manufacturing
    • 700 & Above Employee
    • Sr. R&D Engineer
      • Apr 2019 - Jan 2022

    • United States
    • Medical Equipment Manufacturing
    • 400 - 500 Employee
    • Product Development Engineer
      • Sep 2015 - Apr 2019

      - Interface directly with customers to determine design inputs and coordinate development activities to meet customer, internal, and FDA requirements- Design and develop delivery systems including catheters (steerable, single/multi-lumen), handles, and capital equipment - Led engineering efforts to develop and re-design a product family to bring to market within one year- Oversee and mentor new Engineers and Interns, coordinate efforts to maximize their development within the organization- Work directly with Quality and Manufacturing teams to mitigate risks, develop robust processes, plan and coordinate resources- Coordinate time and train Technicians, Operators, and Engineers on Manufacturing Procedures and GDP- Develop new concepts from initial design to market release through the Product Development Life Cycle- Develop medical devices using techniques such as coiling, braiding, reflow, laser bonding, hot-jaw bonding, adhesive bonding, heat-setting, and nitinol forming- Generate technical documentation such as Design History Files, Root Cause Analysis, SolidWorks CAD Drawings, Component Specifications, Risk Management Documents, Product/Process Validation Protocols and Reports, Technical Reports, Manufacturing Procedures, Inspection Protocols, and Test Methods-Work with suppliers for procurement of equipment and raw materials (materials range from off-the-shelf to custom-designed machined/molded components)- Develop and execute test methods using equipment such as tensile towers, laser micrometers, pressure/burst testers, track machines, anatomical models, and vision systems

    • United States
    • Medical Equipment Manufacturing
    • 700 & Above Employee
    • Software Engineer
      • Jun 2014 - Sep 2015

      - Test Automation of Linux-based Class II medical software application used in surgical procedures to help correct abnormal heartbeat- Reduced manual test effort by 95% by converting manual tests containing Software Requirement Specifications to automated tests using python-based test automation framework- Trained and mentored new team members (internal/external) to help familiarize with product, verification and validation procedures, and good automation practices- Trained offshore contract team, coordinated and prioritized efforts between internal and offshore group, managed offshore personnel to bridge gap between internal and offshore teams- Developed, performed production testing, and automated test code following practices that meet FDA guidelines for medical device software - Performed problem analysis, bug replication and isolation, and analyzed manual tests to determine if efforts worth expending in the conversion from manual to automated test protocols- Led test validation reviews and created training documents regarding coding standards, test maintenance, automation tools, application guidelines, and code review processes/standards

    • Software Engineer Intern
      • Jun 2013 - Jun 2014

      - Test Automation of Linux-based Class II medical software application used in surgical procedures to help correct abnormal heartbeat- Convert manual tests containing Software Requirement Specifications (SRSs) to automated tests using python-based test automation framework, reducing manual test effort by 95%- Develop, perform production testing, automate test code following practices that meet FDA guidelines for medical device software; lead test validation reviews- Perform problem analysis, bug replication and isolation, and analyze manual tests to determine if efforts worth expending in the conversion from manual to automated test protocols

    • Undergraduate Research Assistant
      • Aug 2012 - May 2013

      - SMURF1 Maintains Cancer Stem Cell Population by Regulating the BMP Switch—designed experiments to test drug resistance in head and neck squamous cell carcinoma cancer stem cell populations- Grew and maintained cancer stem cell cultures and performed experiments such as RNA extraction, qPCR, transfection, knockdown, MTS, and other chemotherapies - SMURF1 Maintains Cancer Stem Cell Population by Regulating the BMP Switch—designed experiments to test drug resistance in head and neck squamous cell carcinoma cancer stem cell populations- Grew and maintained cancer stem cell cultures and performed experiments such as RNA extraction, qPCR, transfection, knockdown, MTS, and other chemotherapies

    • Undergraduate Research Assistant
      • May 2012 - May 2013

      - Analyzed biomedical data using data mining, machine learning, and statistical algorithms- Developed and maintained algorithms for data manipulation and analysis using Linux, MATLAB, Python, pre-developed algorithms run in terminal- Collaborated with School of Nursing to use data mining techniques on clinical data- Publications: "Data Mining to Predict Mobility Outcomes for Older Adults Receiving Home Health Care", AMIA 2013, "Mining Patterns Associated with Mobility Outcomes in Home Health Care", Nursing Research, 2015

    • Undergraduate Research Assistant
      • Jun 2011 - Aug 2011

      - Preparation of Gold-Coated Magnetic Nanorods for Lung Cancer Treatment—designed experiments attempting the use of gold-coated magnetic nanorods for site-specific lung cancer therapy using aerosols; aided in creating advancements in possible tumor cell death - Utilized equipment to perform particle size analysis, UV scans, and basic lab equipment such as centrifuges- Presented research experiments, analyses, and findings in Undergraduate Research Symposium (Apr 2012) o University Digital Conservancy permanent link: http://purl.umn.edu/132227

Education

  • University of Minnesota-Twin Cities
    Biomedical/Medical Engineering
    2010 - 2014

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