Yongji Fu

As a Vice President Research and Development, and Global Testing Center, I lead global R&D strategy for our medtech products in infusion therapy and diabetes care in a multinational medical devices group. I direct a multi-site medical devices engineering organization across APAC and Europe, with a focus on NPD portfolios, global team management and cross-functional leadership in a regulated Class II and Class III device environment. I set the innovation roadmap and technology roadmap for infusion therapy, diabetes care and digital health, guiding early-stage innovation, feasibility studies and proof of concept work in sensing technologies, physiological sensing, wearable devices and connected devices. I align portfolio management, strategic planning and technical strategy with clinical needs, regulatory strategy and manufacturing scale-up. I oversee prototype development, test engineering and design reviews using systems engineering, stage-gate process, requirements management, voice of customer and DFMEA, PFMEA, DFM and process validation to secure high-quality product launch and clinical evidence. I establish AI Expertise such as Digital Twin, Generative Design, and AI-based material research, to optimize the innovation efficiency. I sponsor global KOL engagement, clinical validation and clinical studies with academic centers and hospitals to strengthen clinical affairs and support PMA, CE marking and MDR compliance. I build and develop technical talent through innovation management and talent development programs in APAC and Europe, foster psychological safety and accountability, and integrate M&A and M&A due diligence projects into the global R&D leadership agenda, ensuring technology commercialization and long-term competitiveness of the infusion therapy and diabetes care portfolio.

As a Director of Early Innovation, Research & Development, I led global innovation programs for connected patient monitoring and digital health at Hillrom, aligning early-stage R&D with corporate strategy and clinical needs. I focused on machine learning, AI algorithms and sensing technologies for vital signs monitoring, patient monitoring and real-time monitoring in acute care settings. I directed cross-functional teams in algorithm development, prototype development and test engineering for wearable sensors, connected devices and remote monitoring platforms. I guided systems engineering, stage-gate process and design reviews. I translated voice of customer, clinical workflows and requirements management into architectures for Respiratory Monitoring, Cardiovascular Monitoring and Vital Signs Monitoring portfolios. I sponsored clinical validation and protocol design with KOLs and academic partners to support clinical affairs and regulatory strategy for SaMD and connected care solutions. I contributed to technology commercialization, portfolio management and strategic planning by building partnerships with startups and universities in AI and physiological sensing. I supported M&A integration activities with technical due diligence and roadmap input, ensuring that sensing technologies, deep learning capabilities and digital health platforms could scale across global product lines. I built a collaborative innovation culture, strengthening team building, talent development and global R&D leadership within the early innovation organization. I drove integration of patient monitoring platforms with EMR, HIS and hospital IT systems, focusing on interoperability, cybersecurity, cloud connectivity, HL7, FHIR and data analytics, and aligned usability engineering, human factors, ISO 13485 quality management and IEC 60601 safety standards with rigorous risk management and regulatory compliance.

As a Technical Manager, Advanced Diabetes Care, I led R&D programs for next generation medical devices in diabetes at Becton Dickinson, with focus on continuous glucose monitoring, insulin infusion sets and automated insulin delivery systems. I translated customer needs, clinical workflows and physiology into product requirements for CGM sensors, insulin delivery components and integrated artificial pancreas concepts in a regulated medical device environment. I directed cross functional project teams across US R&D sites in system architecture, algorithm development, hardware design, sensor development and usability engineering. I coordinated design inputs, design verification and design validation activities in line with ISO 13485, IEC 62304 and risk management for diabetes devices. I worked with manufacturing, quality and regulatory teams to secure design transfer and prepare submission packages. I established and led global university collaboration programs with institutions such as Harvard, Cambridge, Duke and Newcastle University. I built strategic relationships for technology commercialization, joint research grants, clinical studies and talent recruitment in diabetes technology and glucose sensing. I supervised clinical analysis activities for first-in-human studies in the US and Canada, including protocol design, regulatory documents, trial data management and statistical analysis for internal decision making and external publications. I helped position BD as an innovation partner in diabetes care across CGM, insulin infusion and artificial pancreas ecosystems.

As a Tech Lead and Senior Research Scientist, Consumer Health, I developed wearable sensor systems for real-time cardiovascular and respiratory disease monitoring in personal health and consumer health applications. I focused on ambulatory monitoring solutions that could capture physiological parameters accurately in daily life settings using compact, low-power hardware and robust algorithms. I designed and implemented digital signal processing algorithms to extract physiological parameters in real time from multimodal sensor signals. I studied sound tissue interaction to estimate airflow from acoustic signals and integrated optical and acoustic transducers into prototypes that enabled respiratory monitoring, cardiovascular monitoring and early detection of disease events. I collaborated with cross-site engineering teams in the United States and India on system architecture, sensor selection, hardware design and embedded software. I led bench testing and human factors evaluations to validate performance, refine algorithms and improve usability for home health and personal health users. I represented Sharp in IEEE 11073 personal health care standard development, contributing technical input on wearable devices, data formats and interoperability. This work strengthened my expertise in physiological sensing, wearable sensor systems, ambulatory monitoring, signal processing and standards-based personal health device ecosystems.

Ph.D. research in Biophotonic Sensing, Imaging, and Therapeutic solutions

Algorithm development for non-invasive blood pressure (NIBP) in Matlab and C++.

Specialist in “SOMATOM Smile” X-ray Computed Tomography (XCT) system.