About the Research Centre
In collaboration with CityU, University of Oxford, and Karolinska Institutet, the Hong Kong Centre for Cerebro-cardiovascular Health Engineering (COCHE) was established with the support of the ITC-InnoHK Programme to develop new ways to tackle cardiovascular disease (CVD), which is the world's leading cause of morbidity and mortality. To address the most pressing health challenges caused by CVD, COCHE focuses on developing innovative technologies such as flexible and wearable devices, biomedical and molecular imaging, nano-biosensing, micro-robotics, healthcare AI systems, and other ground-breaking methods to enable early prevention, diagnosis, and intervention of the disease. These technologies can reduce human costs while alleviating financial and social burdens on the healthcare system. For more information on COCHE, please visit: https://www.hkcoche.org/
Job Description
As the Lead Engineer, you will play a crucial role in ensuring that our technologies meet all industry standards, regulations, and guidelines. You will be responsible for leading a team of engineers to provide technical expertise and support the commercialization processes of our projects, in particular overseeing prototyping, product development and optimization.
As a member of our team, the successful candidate will be responsible for:
• Continuously monitor changes in industry standards, regulations, and compliance requirements relevant to the company's products and operations. Stay informed about emerging trends and best practices in compliance.
• Develop and implement strategies, policies, and procedures to ensure the company's products and operations align with industry standards and regulatory requirements. Work closely with cross-functional teams to integrate compliance practices into product development, manufacturing processes, and quality control.
• Collaborate with commercialization teams, clinical study team and other relevant stakeholders to address compliance requirements at every stage of the product lifecycle. Guide and provide expertise to ensure compliance from design to manufacturing to distribution.
• Serve as the main point of contact for prototype/product development for all Centre’s commercialization projects and engage in regular communication and reporting as required.
• Conduct training sessions and workshops for employees on prototype/ product development
• Keep abreast of emerging regulations and industry trends related to product development. Proactively assess the impact of these changes on the company's operations and develop strategies to comply with new requirements.
General Qualification
• Master’s or Bachelor's degree in Engineering or a related field. Advanced degree preferred.
• At least 5 years of experience in a product technical development, showing relevant experience on regulatory compliance in medical devices is preferred.
• Proven experience and in-depth knowledge of updated relevant industry standards, regulations, and guidelines.
• Strong leadership skills with the ability to effectively manage a team and drive projects to completion.
• Excellent analytical, problem-solving, and decision-making abilities.
• Exceptional communication and interpersonal skills.
• Attention to detail and a high level of accuracy.
• Ability to adapt to changing regulations and work effectively in a fast-paced environment.
Preferred Hiring Qualifications:
Remuneration & Duration of Appointment
The remuneration package will be highly competitive, and commensurate with qualifications and experience. Fringe benefits for full-time appointments include leave and medical insurance, etc. The possibility of re-appointment after the initial contract period will be based on performance evaluation and mutual agreements.
The application Materials that Should be Included
Application Closing Date:
The post is immediately available. Consideration of applications will be open until the position is filled.
Additional Information/links:
Application Procedures:
Kindly submit your curriculum vitae (CV) and a cover letter, providing a comprehensive overview of your relevant experience and explaining why you are the most suitable candidate for this position. Additionally, please include your current and expected salary details. Kindly send these documents to hr@hkcoche.org, mentioning the job advertisement number LE. Please note that only shortlisted candidates will be contacted.