职位详情
职责
- 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
入职条件
- 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
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.
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.
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.