Cecilia Xi

About Cecilia Xi

Years of experience in a broad range of class II and medical devices including pacemakers, ICDs, CRTs, subcutaneous monitors, left atrial pressure systems, SCS devices, remote care systems, devices for cardiothoracic surgery, intravascular robotics and wireless telehealth (IoHT) wearable devices• Excellent leadership and vision; superb interpersonal and communication skills; relentlessly driving across functions from early concept to post-market; continuously providing medical liaison and technical direction; fitting well from startups to large companies• Extensive expertise and versatile hands-on experience in strategic marketing, business development, pre-clinical & clinical research, innovation, medical affairs, systems architecture & engineering, human factors, program management, quality and regulatory• Hands-on QA and regulatory experience, filing for FDA 510k and CE (class II); familiar with IEC 60601-1, ISO 13485, ISO 14971 and FDA 21 CFR 820• In-depth medical and product knowledge with strong personal passions; good at creating product portfolios to meet unmet market needs with strategic product design to differentiate the company’s technical strengths; Certified Cardiac Device Specialist• Strong presentation, communication and writing skills (multiple journal publications & conference presentations; presentations to KOLs, executives, partners, VCs and the board; IFU and user manual writing)• Highly innovative (with many granted and pending patents covering heart failure, inappropriate therapy, AF monitoring, pacer and ICD leads, CRT optimization, multi-electrode lead, neuromodulation, telehealth ECG and thermometers); “Innovation Pioneer Award” recipient; extensive invention disclosure and patent application review experienceSpecialties: Strategic Project Planning, New Business Development, Medical Affairs, Customer Research, Unmet Needs Identification, System Definition and Design, Trade-Off Analysis, Feature Design and Algorithm Development, Risk and Interaction Analysis, IP Development and Strategy, Pre-Clinical and Clinical Study Design and Management, Contextual Inquiry & Workflow Analysis, Usability Testing, System Validation, Quality, Regulatory

Experience

1. VP Clinical and Scientific Affairs

   Vivalink

   Oct 2025 — Present

Education

• Northwestern University

  PhD, Biomedical Engineering