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 current 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, organize and execute Informative tests when needed,



and formal tests by external test houses according to norms like IEC60601 family of standards, including their national deviations
- Be the main engineering contact for Product Certification Bodies and Test houses
- Support R&D; personnel for Safety and Regulatory related questions and issues
- Mechanical, environmental, and electrical safety, and electromagnetic compatibility (EMC/ESD)
- Material compliance to REACH, RoHS and WEEE, parts classification
- Support EPCs, Technical Files, 510(k), CE, and regional submission documentation.
- Discuss with test sites (TUV, MECA, NRTL, CB) and internal QA to clarify if/which test are needed for changes on safety related parts. Document tests and rationale for ‘No-test-needed’ as applicable along with product variability assessment.
- Risk management for device design: Develop and maintain regulatory documentation, including regulatory submissions, technical files, and design history files, ensuring compliance with applicable standard

📌 Lead Engineer 1 (Bengaluru)
🏢 GE Healthcare
📍 Bengaluru