R+D Engineer, Membrane
CurrentProcess Engineering ▪️ Lead cross functional team to quantify impact of sensor membrane chemistry and manufacturing processes on build-to-build variability . ▪️ Executed DOE’s to identify, characterize, and measure influence of raw material critical process parameters on final sensor performance. ▪️ Defined raw material product specifications for reliable glucose sensor manufacturing and final sensor performance.System Engineering ▪️ Formulated glucose sensor next-generation polymer membranes for improved robustness across activity, performance, and material lifecycle. ▪️ Identified and addressed system error bias contributed by variability in hardware manufacturing and calibration procedures. ▪️ Correlated sensor manufacturing process parameters to in-vivo clinical performance for closed loop product development. Assay Development, TMV, and MSA ▪️ Designed, validated, and documented several assays and associated software for sensor and system level performance under high stress conditions. ▪️ Managed multi-disciplinary initiatives with key stakeholders to streamline in-line raw material testing and lifecycle management. ▪️ Set acceptance criteria for sensor performance metrics while developing high throughput test methods to address feature specifications. Quality ▪️ Documented test procedures, SOPs, lab bench reports, product specification requirements, installation and qualification protocols (IOQ/PQ), and raw material specifications. ▪️ Filed customer complaint medical device reports (MDRs) with FDA and foreign regulatory bodies with Quality and Regulatory Affairs teams. ▪️ Assisted in sourcing second suppliers for sensor manufacturing raw materials.