Kai Thanasitsomboon

• Engineer a novel ex vivo pulsatile perfusion system capable of simulating physiological cardiac blood flow dynamics for testing cardiovascular devices • Design vessel adapter devices using SolidWorks • Collaborate on and executed pre-clinical studies by drafting IACUC protocol and performing microsurgery to validate device functionality • Facilitate the revival and maintenance of human hearts (declined for transplant) using a perfusion system to restore sustained mechanical beating for research and testing • Support the deployment and functional assessment of novel cardiovascular devices onto the beating heart, ensuring proper setup and data collection • Shadow robotic surgery

• Wrote protocols/reports and execute Equipment Qualification (IQ/OQ/PQ) to ensure that new equipment/instruments/machines can perform as expected per company’s requirements and/or operating manuals • Evaluated the risk on equipment change controls and determine necessary implementing and/or testing actions • Drafted nonconformance reports detailing validation protocol deviations, root cause analyses, and corrective actions to ensure compliance and prevent recurrence • Performed temperature mapping on temperature-controlled storage units to verify sensor reading accuracy

• Write protocols/reports and execute Process Validations (IQ/OQ/PQ) to ensure that new equipment/machine can perform at the production rate and follow the requirements of 21 CFR 820 and ISO 13485 • Use Minitab and utilize quality measurement tools (e.g., Capability Analysis) to investigate if the products are statistically able to meet the acceptance criteria/specifications • Evaluated the risks of new machines using FMEAs and Process Control Plans • Review manufacturing work orders and device history records for 510(k) remediation and IVDR studies to ensure that the production, sterility, and irradiation meet specific requirements per R&D requests

• Participated in Undergraduate Research Opportunities Program (UROP) and awarded with UROP stipend (May 2019 to July 2019) • Researched atrial fibrillation (AF) by utilizing MATLAB to better understand how AF affects blood flow • Segmented cardiac MRI data using Seg3D to model ventricles and collect blood flow rate • Analyzed pre- and post-AF data by performing statistical analysis t-test on MATLAB to quantify the significant difference and interpret the results that AF alters blood flow behavior

• Monitored the performance of devices that have been released to market and detected any potential safety, product quality, or regulatory issues (Class II and III devices) • Outlined Post-Market Surveillance Plans and Periodic Safety Update Reports to capture sale/complaint data • Reviewed CAPAs, MRRs, SAs, FAs for accuracy/completeness to assure regulatory compliance (MDR) • Supported third party audits for EU MDR with zero nonconformities

• Class: Fundamentals of Biomedical Engineering II (BME 2100) • Taught students how to use MATLAB and simulate blood pressure of cardiovascular system by running script files • Guided students how to assemble Op Amp and RC circuits, combining with oscilloscope to generate waveforms that mimic left ventricular blood pressure pattern

• Researched on solar cell and experimented on optimizing spray pyrolysis conditions to synthesize zinc oxide (ZnO) films • Collected data from measuring optical band-gap via a UV-Vis spectrophotometer • Interpreted data using statistical visualization on Excel and fabricated the optimal ZnO solar cell films • Designed a laboratory protocol with complete instruction for student projects in General Chemistry III

• Subcomittee of Biomedical Engineering Society (BMES): 2018-2019 • Undergraduate Researcher in Cardiac Electrophysiology, Nora Eccles Harrison Cardiovascular Research and Training Institute (CVRTI) • Teaching Assistant for Fundamentals of Biomedical Engineering II

Full scholarship granted through the WCC Foundation (W. Robert Simpson Scholarship)