Summary Experience Education Skills Other Links

Versono Medical Ltd.

Principal Electronic Engineer, Jan 2021 – Present

Versono Medical is a medical device startup company based in Galway.
They have developed an electro-mechanical device for endovascular surgery, known as FastWire.

When I joined the company in 2021, there was a very basic proof-of-concept prototype, but no more.
There was also zero in-house expertise in the area of electronic engineering, or software development.
My task was to take the product concept and commercialise it.
At the time of writing, the FastWire device has successfully completed First-In-Human clinical trials and is going through the FDA's regulatory approval process.

Achievements ...
ResponsibilityAchievements
Hardware Development
  • Created a Quality Procedure (Standard Operating Procedure) for hardware development, compliant with IEC 60601-1.
  • Made the decision to end all engagement with the external company who had been contracted to develop the Controller.
  • Selected an alternative supplier, and a new architecture, to develop the Controller.
  • Specified all hardware sub-assemblies and components.
    • Selected an off-the-shelf medical-grade power supply.
    • Specified all electromechanical elements: connectors, cables, UI membrane, etc.
    • Worked with the Actuator supplier to arrive at a design that was cost-effective, low-power, and safe.
  • Successfully transferred the Controller design into production.
Software Development
  • Created a Quality Procedure (Standard Operating Procedure) for software development, compliant with IEC 62304.
  • Managed the development of the embedded software in Verilog.
  • Created Python scripts for automatic content deployment from manifest files.
Test & Verification
  • Created and executed multiple test protocols and test methods.
  • Successfully completed electrical safety testing (IEC 60601-1) in an accredited test house.
  • Successfully completed EMC testing (IEC 60601-1-2) in an accredited test house.
  • Created multiple Python scripts for test automation.
Other
  • Learned how to execute product development withing the constraints of a Quality Management System.
  • Learned how to apply the principles of risk management to product development.
  • Hired 2 graduate engineers into the electronics team; managed the team.
Training ...
CoursePresenterDateDays
Manual HandlingClarke ConsultingTBCTBC
Technical WritingSQTTBCTBC
Medical Software Quality AssuranceUniversity of Limerick / Irish Medtech AssociationTBCTBC