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AI Engineering Specialist (Software as a Medical Device (SaMD) and Artificial Intelligence)
Job Function
- Information Technology
- Project Management
Discipline
- Biomedical Sciences
- Data Science
Years of Experience
- 7-9 years
Responsibilities
- 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
Requirements
- 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.
Additional Information
- 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
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