Responsibilities:

• Assist in the medical device product realization process. 
• Assist in maintaining product realization timeline.
• Plan and implement product realization documentation, such as user requirements, design input, and device specifications in accordance with Regulatory standards (ISO 13485, etc.).
• Ensuring effective and comprehensive communication throughout the production realization between different stakeholders and multiple manufacturing sites.
• Lead and communicate with different parties in resolving engineering design, risk management, product quality, and testing issues during product realization.
• Lead and issue Engineering Change and communicate with necessary parties through the documented process. 
• Participate and support Risk Management activities.
• Participate and support Corrective and Preventative Action activities.
• Participate and support Design Verification and Validation activities.
• Participate and support in Technical File and Design Dossier Submission.
• Completing any tasks within the project scope including design verification and validation activities, design, artwork, regulatory submission, product registration, transfer to production, and so forth.
• Participate and support customer communication as required.
• Complete other tasks as assigned.

Requirements:
 

• Bachelor’s degree in Engineering Discipline. 
• Three years in engineering work-related discipline is preferable. 
• Strong interpersonal and communication skills.
• Strong logical understanding and hands-on solution provider.
• Ability to adapt to fast-paced environment.
• Task-oriented and proactive team player.
• Experience in product realization-related discipline is preferable.
• Experience in the medical device-related area is preferable. 
• Engineering Associate position will be considered for an applicant with lesser experience.
• Senior Project Engineer position will be considered for an applicant with greater experience. 

Additional Information

 - To be considered for this position, you need to be legally eligible to work in Hong Kong.
 - Due to the high volume of applications, we will be contacting successful candidates only.
 - GA Health is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.