Responsibilities:

1.New Products Introduction
2.Production process set up, verification, validation, optimization
3.Production documentation creation
4.Production / Installation technical support and troubleshooting
5.SCM related Nonconformity follow up and problem solving
6.Support internal & external audit
7,Other Process engineering activities defined in SOPs


Qualifications and experiences:

-Have more than 5 years of work experience in the process engineering of Class III medical devices
-Be familiar with medical device regulatory standards such as FDA QSR, ISO 13485, GB/T 42061, etc.,
-Be able to integrate regulatory requirements into the process design and production process to ensure product compliance.