In addition to my experience in consumer product and robotic industries, I am also well-versed in development of medical devices. I have worked on Class II and III medical devices, particularly for vascular diseases.

I have worked in R&D and reliability engineering roles, so I am very familiar with:

  • Validation and verification testing
  • Test development (Gage R&R)
  • Product lifecycle management
  • Pilot manufacturing
  • GD&T & statistical tolerance analysis
  • Corresponding with regulatory agencies (U.S. FDA, Japan’s PMDA)
  • Post-market surveillance (CAPA reporting)

If you are in need of some guidance for this specialized area, get in touch with me!