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!