• Lead the design and development of AI/ML algorithm
• Focus on electrophysiology and brain-computer interface (BCI) data analysis and algorithms
• Apply your expertise in machine learning (especially deep learning) to develop, train, validate, and optimize algorithms for a variety of medical applications
• Architect and develop SaMD products, with a focus on US FDA product registration (510(k), De Novo, PMA) and fulfilling international standards (e.g., ISO 13485, IEC 62304)
• Employ software engineering best practices and adhere to relevant software development cycle standards
• Guide architectural decisions, technology choices, and development methodologies
• Collaborate with cross-functional teams (product, clinical, regulatory) to ensure alignment

• Bachelor, Master or Ph.D. degree in Computer Science, Data Science, Biomedical Engineering, Information Engineering, or a related field with a strong emphasis on software development and AI/ML.
• Proven experiences in BCI related data analysis and algorithms
• Proven experience in handling brain-related electrophysiological signals such as ECoG, neural spikes or EEG as a plus
• 6+ years of experience in software development for medical applications, with 3+ years focused on SaMD and a proven track record of developing and deploying AI/ML algorithms in a regulated environment.
• Expert-level proficiency in machine learning, particularly deep learning, with hands-on experience using frameworks and tools, such as TensorFlow, PyTorch, Keras, etc.
• Strong programming skills in languages such as Python, C++, R, and Java.
• Experience with cloud computing platforms (AWS, Azure, GCP) and their services relevant to SaMD.• In-depth understanding of the medical device development lifecycle and relevant regulations (FDA or EU MDR). 
• Experience with SaMD development, verification, validation, and regulatory approval.
• Knowledge of QMS principles and ISO 13485.

• Full-time / part-time, details can be negotiated
• Located in Hong Kong, or the Silicon Valley area in California in US
• Highly competitive compensation will be offered.
• Knowledge of QMS principles and ISO 13485.

ABIC Ref.: H01/2025/022

The personal data provided in your application process will be used for recruitment and other employment-related purpose. The personal data may be transferred and disclosed to, and used by HKU Innovation Holdings Limited and The University of Hong Kong for the above purposes.