职位详情
职责
- 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
入职条件
- 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.
附加信息
- 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.
关于公司
概述
The mission of the Advanced Biomedical Instrumentation Centre is to accelerate progress in translating advanced biomedical instrumentation from research and development into real-world healthcare solutions that benefit people in Hong Kong and around the world. The Centre aims to foster collaboration among top-notch engineers, scientists and clinicians in the US and Hong Kong to develop next-generation microfluidics and low-cost instrumentation technologies. It also takes advantage of Hong Kong’ s vibrant start-up community to commercialise the research work tailored for Asian patients.