Position Overview
**Job Description Summary**
As a Lead Engineer 1 - Safety & Regulatory Engineer, you will be responsible for ensuring the safety and regulatory compliance of Wipro GE Healthcare's medical devices throughout their lifecycle. This role involves leading safety risk management activities, interpreting and applying global medical device regulations, and collaborating with cross-functional teams to achieve regulatory approvals and maintain product safety. You will also coordinate technical documentation for the Notified Body approval process.
**Job Description**
Job Responsibilities:
+ Lead and execute safety risk management activities for new product development and sustaining engineering projects, including hazard identification, risk analysis, and risk control verification.
+ Interpret and apply relevant global medical device regulations and standards (e.g., FDA, MDR, IEC 60601-1 and other applicable standards) to product design and development.
+ Plan,...