Software Skills
C
Fortran
Microsoft Office
Microsoft Excel
Microsoft PowerPoint
Microsoft Visio
Microsoft Word
Sector Experience
Aerospace & Defense
Energy
Life Sciences & Pharma
Languages
English
Experience
Livongo Health
Engineering
Sr. QA Engineer, Verification & Validation/Sr. Technical Writer
9/2018 - 12/2020
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.
Blue Sages
Engineering
Sr. SW Engineer/Sr. Systems Verification/Validation Engineer – Verification and Validation
3/2018 - 5/2018
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.
Accel Biotech
Engineering
Senior Systems Verification/Validation Engineer – Verification & Validation
7/2015 - 1/2018
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.
Lutronics
Engineering
Technical Lead Senior Systems Software/Hardware Engineer - Verification and Validation
5/2011 - 11/2011
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.