Compose documents for FDA submittal for various product lines. Work with engineers and supply chain to create and maintain Engineering Change Orders and BOMs for part numbers and documents within Arena. Execute Product Verification and Validation test protocols.

Organized and wrote Manual Test Protocols for a Class 3 Medical Device for a client of Blue Sages in Mountain View, CA. Ran weekly full system Smoke Test on a Class 3 Surgical device.

Verification/Validation of Class 2 Biotech IVD devices through written test cases. Oversee formal testing for 510k submission to FDA, as well as write formal test reports. Have written documents for testing as well as Software Verification Plan, Master Verification Plan, Level of Concern, System and Software Traceability Matrix and other Design Assurance documents. Been part of formal reviews for Software/Firmware Requirements Specifications, Code reviews.

Lead a small team of testers to complete V&V testing on a new Class 3 laser system. Design and executed new test plan and cases for new system for the GUI interface and controller software/hardware. Created Traceability Matrix for system Used Bugzilla to track bugs found during V&V testing.