Hello! I am a medical device specialist that’s focused on delivering high quality devices to meet rigorous standards. I have a background in software, medical device software including SaMDs, mobile applications, cloud systems, AI implementation, and embedded software development.I have experience working as a software quality engineer in testing, reporting, and evaluating FDA regulated medical devices. This experience extends to manual and automation testing, design control implementation, test plan development, documentation writing, SOP and process improvement, risk estimation and other systems and design engineering responsibilities. I have a strong understanding of international engineering standards and their implementation in existing or emerging work streams. ISO 9001:2015, 13485, 14971, IEC 62304 and 21 CFR 820.