• Develop and execute comprehensive product development plans that align with our Centre’s strategic objectives
• Manage project scope, timelines, budgets, contractors, and resource allocation
• Manage the design and manufacturing control process, including user assessment, design conception, verification, validation, design transfer, and quality assurance
• Oversee the whole manufacturing process from start to finish, and in charge of organizing and coordinating all departments involved, from design and engineering to production and quality control
• Work with scientific innovators and invention developers to engineer novel technological solutions for product breakthroughs
• Identify and manage relationships with clinical research organizations (CROs) and clinical investigators.
• Liaise with project teams, suppliers and clients
• Ensure compliance with relevant standards and regulations (e.g., FDA, IVD-R, ISO 13485, IEC 60601, IEC 62304, EU MDR, etc.).
• Oversee the preparation and submission of regulatory filings (e.g., 510(k), PMA, CE marking, etc.) to obtain marketing authorization.
• Interact with regulatory agencies (e.g., FDA, notified bodies) to resolve issues.
• Ensure that all product development activities are conducted in accordance with Quality Management System (QMS).
• Analyze manufacturing process to identify any opportunities for improvement or cost savings

• 8+ years of experience in medical device product development, with a proven track record of successfully bringing products from concept to commercialization
• 4+ years of experience in a senior role in project management, managing complex, multi-disciplinary projects
• Experience with deep tech and healthcare products (e.g., those involving AI/ML, biomedical software, medical big-data, novel materials, advanced sensors, medical implants, diagnostic devices, etc.) is highly desirable.
• Strong knowledge of QMS and medical device regulations (e.g., FDA QSR, ISO 13485, IEC 60601, IEC 62304, EU MDR, etc.).
• Familiar with clinical trial designs and clinical development management
• Expertise in at least one of the following areas:- Brain-Computer Interface (BCI)- Biomaterials or Bioelectronics for Electronic Skin- Interventional Cardiology or Interventional Radiology- Organoids- Orthopedic Implants- Point-of-Care Testing (POCT) Devices for Pathogens or Chronic Diseases
• Bachelor, Master, or PhD degree in Engineering or Life Science related disciplines

• 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.

ABIC Ref.: H01/2025/021

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.