-Lead system integration sub-projects relating to instrumentation systems and assays of a FDA cleared point-of-care medical instrument by writing scripts for automating processes.-Lead design reviews related to scripts and software updates for the purpose of process improvement and troubleshooting.-Responsible for analyzing and interpreting data to guide assay design and optimization. Supported technical submissions for 8 products that received CE Mark, 1 product that received FDA 510K, 2 products that received FDA de novo approval.-Designed V&V experiments to determine LOB/LOD/LOQ, Precision, Linearity, Prozone Effect, Kinetics, and Method Comparison for 4 different biomarkers based on Fluorescent Resonance Energy Transfer (FRET) technology.

-Developed scripts using VENUS software and running/troubleshooting methods for automated lab processes using Hamilton Liquid Handlers.-Analyzed large data sets and mined information from large databases using R to find correlations and trends associated with multiple diagnostic products.-Wrote Excel Macros to help assemble large data sets into custom formats.-Conducted wet lab experiments including sandwich ELISA assays, Luminex assays, and MSD assays.

-Worked as a prep lead in the drug product manufacturing department and worked in ISO certified cleanrooms for formulation, filtration, and filling operations.-Performed technical writing including writing deviation reports, SOP’s, Out of Specifications reports, preventive actions, change control requests, and master batch record revisions.-Conducted internal audits and collaborated with validation department to maintain manufacturing equipment such as autoclaves and depyrogenation ovens.-Collaborated with operational excellence 6 sigma team to streamline manufacturing processes.

Primarily did programming in the context of image processing. Used Xcode to develop a mobile image processing app with similarities to ImageJ.

Conducted independent research on the topic of tissue engineering. Gained experience working with cells as well as working with biomaterials and running assays including alamarBlue staining, Calcein-AM live/dead staining, and stiffness testing via Instron.

Worked as a software and hardware tester, focusing on blood-glucose meters.