Job ref no.: CT3130503-01#0006
GA Health Company Limited

Project Engineer (Medical Device)

GA Health Company Limited

Job Description

  • Prepare medical device product documentation including, but not limited to, detailed drawings, Bill of Materials (BOM), device specifications, and inspection criteria as directed.
  • Utilize engineering system to develop design dossier and engineering change notice, as needed.
  • Assist in medical device product realization in a timely matter.
  • Participate as directed in resolving engineering design, product quality, and testing issues of medical products.
  • Participate in product risk management and design verification and validation activities
  • Assist in regulatory submission.
  • Communicate with operation staff and manufacturing vendors to optimize design concepts for cost, quality, and manufacturability.
  • Review on tool designs, first-article components, sub-assemblies, and finished products.
  • Support manufacturing and sustaining efforts throughout product lifecycles.
  • Any other tasks assigned by supervisor.

Job Requirement

  • Bachelor’s degree / Higher Diploma in Engineering or Science Discipline
  • Over 3 years of relevant working experience, fresh graduate with knowledge of medical devices or ISO 13485 regulatory will also be considered.
  • Good knowledge of Mechanical Assemblies, geometric dimensions, tolerance & product risk analysis, and Pro-E 3D CAD/CAE software will be a plus
  • Knowledge in manufacturing processes for prototyping, fabricating, and finishing of metal and plastic components.
  • Strong understanding and experience in medical irrigation tubing or tubing assembly will be a definite advantage.
  • Professional management for part number, BOM, and engineering change.
  • Ability to accurately inspect first article parts and perform design verification tests.
  • Ability to perform root cause analysis on failures and implement design improvements.
  • Task-oriented and proactive team player with strong analytical and logical thinking skills.
  • Working experience in Medical Devices and Surgical Devices is preferred.
  • Immediate available preferred.  
More job information
Job ref no. CT3130503-01#0006
Salary
Job Function
Industry
Location
  • Shatin
Employment Term
  • Full-time
Experience
  • 3 years - 8 years
Career Level
  • Middle management level
Education
  • Asso. Deg or High Dip
  • Degree
Benefits
  • 5-day week
  • 13-month pay
  • Discretionary bonus
  • Flexible working hours
  • Medical plan