In this role, you will be responsible for GE Healthcare anesthesia machine safety qualification &
regulatory certification. As this role, you need to provide the input to engineering/program
team with clarification, training and guidance if necessary. Guide and support relative
verification test engineers to performing safety standards compliance testing. Coordinate with
3
rd party laboratories to perform the test due to the requirements of the IEC 60601-1, GB9706.1
series and other relevant standards, and obtain the certification report from notify body for GE
Healthcare anesthesia machine.
Key Responsibilities
• Stay on current relevant Standards and assess the impacts of the changes with SRB.
• Provide the input to engineering/program team with clarification, training and guidance
to engineering/program team regarding safety standard requirements.
• Define test input requirements (PTR), work with engineering/program team and testing
laboratory in completing appropriate test activities as well as obtain the test report.
• Take responsibility for the safety test plans and reports.
• Interface with internal engineering /program team and external testing laboratories
(TUV, Intertek, CMTC i.e.) in arranging and conducting testing.
• Clarify internal customer’s facility and test needs to assure laboratory meets internal
customer’s and external testing laboratory's requirements.
• Support the engineering/program DCP activities, as well as internal/FDA (Mock)/NMPA
QMS i.e. audit.
• Support (NMPA, MDR, 510K) registration and other regulation relating activities (CCN).Required Qualifications:
• Bachelor or Master degree with major in Electrical engineering, Automation
engineering, Information Engineering or Telecommunications engineering, etc.
• 3 years or above of relevant working experience is preferred.
• Knowledge of Anesthesia Respiratory, and work experience in medical device (active,
class Ⅱ/Ⅲ) research and development is preferred.
• Demonstrated capability to pursue tasks completion, problem solving and results
orientation, ownership spirit as well as multi-task management ability.
• Knowledge of Quality Management Systems for the medical device industry
• Knowledge of the ISO18562/IEC60601/GB 9706.1 standards for medical device (active,
class Ⅱ/Ⅲ).
• Experience working for/with safety testing laboratories (TUV, Intertek, CMTC i.e.)
• Good teamwork spirit in a multi-site working culture, energizing, positive and self
motivation.
• Smart personality and communication skills are preferable.
• Good English skills in reading, writing and speaking.