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 of project management experience is preferable.
Strong interpersonal and communication skills.
Strong logical understanding and hands-on solution provider.
Ability to adapt to a fast-paced environment.
Task-oriented and proactive team player.
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.

All applications applied through our system will be delivered directly to the advertiser and privacy of personal data of the applicant will be ensured with security.

Full-time