Jonathan Li is a dedicated Senior Principal Engineer in Research and Development (R&D) at Edwards Lifesciences, where he plays a pivotal role in advancing medical device innovation. With a strong focus on usability engineering, Jonathan has led critical activities to ensure that commercialized devices meet...
Jonathan Li is a dedicated Senior Principal Engineer in Research and Development (R&D) at Edwards Lifesciences, where he plays a pivotal role in advancing medical device innovation. With a strong focus on usability engineering, Jonathan has led critical activities to ensure that commercialized devices meet stringent regulatory requirements, particularly in support of the European Union Medical Device Regulation (EU MDR) submission. His expertise in establishing usability profiles, utilizing historical data in accordance with Annex C of ISO 62366-1, has been instrumental in enhancing the safety and effectiveness of medical devices. By integrating usability profiles into comprehensive risk management frameworks, Jonathan ensures that user interactions are meticulously analyzed and documented, culminating in the creation of detailed Usability Engineering Reports and Usability Engineering Files.
In addition to his usability engineering efforts, Jonathan has successfully completed feasibility analyses for the implementation of innovative device concepts, showcasing his ability to blend critical thinking with creativity. His technical proficiency spans a wide range of skills, including root cause problem solving, complaint investigations, and design verification testing. Proficient in programming languages such as C++ and C, as well as hands-on experience with Arduino and circuit design, Jonathan is adept at bridging the gap between theoretical engineering principles and practical application. His background in materials science and cell culture further enriches his capability to contribute to multidisciplinary teams focused on technology product development. As a hard-working and driven professional, Jonathan remains committed to improving healthcare outcomes through the design and development of cutting-edge medical devices, all while fostering a collaborative team environment that values innovation and excellence.
