Worked with Combination Product Engineering team to complete development, testing, and documentation required to file an IND for an innovative product comprised of differentiated stem cells encapsulated inside a retrievable, immune-protective device• Developed and optimized a cell loading protocol to deliver beta cell precursors (PEC-01™) into encapsulation devices (Encaptra®)• Wrote supporting SOP and IQ/OQ for a newly developed system and downstream equipment• Cultured PEC-01 cells using aseptic technique for use in process development• Developed acceptance criteria for aggregate distribution inside the encapsulation devices• Conducted optimization of process flow in the manufacturing suite for final product (VC-01™)• Executed feasibility testing of manufacturing processes of VC-01 from cell culture to packaging• Designed and executed tests to determine specifications for manufacturing equipment, fixtures, and in-process disposables• Ran validation testing of sterilization process for disposables using tensile testing

Worked with Sensor Support and Research and Development teams to mature a new sensor/infusion set from final stage design to manufacturing production line•Tested various adhesives for use on product by determining ideal pull force, viscosity, cure time, and effect of IPA on mechanical properties•Performed characterizations on the patch weld, septum cap weld, and adhesive dispensing (timing, pressure, and resulting cure properties) using DOE software on Minitab•Wrote engineering reports to prove, by particle count testing, that parts were clean upon arrival from the vendor, which saved time and cost of extra cleaning before assembly and reduced chemical stress on the environment•Applied clear communication skills as a member of a cross-functional project team to coordinate experiments and ensure that the project moved forward