Jeffrey R. Email and Phone Number

• Developed an approach for usability analysis for IVD products based on ISO 62366, 14971, and 24971• Supported the creation and maintenance of medical device and CDx development deliverables including: V&V plans/protocols/reports, Clinical Risk Assessments, DHF’s, DMR’s, FMEA’s, Material Specifications, and SOPs• Designed and implemented a new system for batch record management and tracking during device design V&V• Trained clinical staff on Good Documentation Practices to support Class II medical device design validation • Collaborated with QA, Regulatory, and R&D to identify and properly document study deviations

• Tasked with improving the previously established point of care immobilization protocol for sensing insulin• Worked with teams to write and perform DOE’s to identify elements that contributed most to sensor variability• Implemented new SOPs that showed improvement to imaginary impedance signals of bound insulin antigen• Performed experiments using Electrochemical Impedance Spectroscopy (EIS) and Cyclic Voltammetry• Collaborated with team to write a scientific publication on the diagnostic capabilities of Faradaic EIS• Functionalized gold nanoparticles on sensor surface and characterized using a scanning electron microscope• Grant funding provided by the Helmsley Charitable Trust

• Reinforced my passion for servant leadership through mentoring students in university physics, general chemistry, medical physiology, and mathematics • Worked 10-13 hours per week to provide students support pertaining to lectures/labs, study techniques and insights for success

• Pursued the goal of elevating and serving the community of Phoenix by working with a team of students to recruit speakers and performers for GCU’s 4th annual TEDx conference • Mentored and collaborated with a biotechnology industry professional for 6 months to formulate a TED Talk that focused on spreading awareness for the counterfeit medicine crisis, along with how her company’s portable drug spectroscopy device could help fix it