Tata Elxsi works with leading medical device OEMs and technology companies for market research and human factor engineering, hardware and software engineering, verification & validation, regulatory standards & compliance requirements along with technologies such as artificial intelligence, cloud and IoT. Tata Elxsi s Medical Device and Healthcare practice is ISO 13485 certified.
Role- System Engineer
Pune- Pune, Viman Nagar
Experience - 4+ Years
KEY JOB REQUIREMENTS: In this role, you will be successful, if you have :
- Proficiency in systems engineering and requirements management.
- Understands Technical System Requirements well and effectively flows down them down into detailed Subsystem/Unit requirements.
- Good understanding of software and hardware systems architecture.
- Write Technical system requirements, review with a cross-functional team, and update in Doors (Requirement Management Tool)
- Drive traceability between TSR to TSSR's and Risk files
- Good knowledge of ISO 14971, Risk management process
- Basic or Expert knowledge about Regulatory standards and identifying applicable requirements to update System documents.
- Basic knowledge about Electronics / Electrical / Mechanical and SW Design.
- Basic knowledge of FMEA and drive DFMEA system level and drive down to sub-system level.
- Verification of Medical device at system level - Test case writing, review, and execution.
- Prepare documentation for regulatory submissions, ensuring compliance with applicable medical device regulations.
- Understanding of System integration plan and test and reporting.
- Excellent documentation and reporting skills.
- Collaborative and able to work with cross-functional teams.
- Good at coordination with External test labs for testing of applicable standards/requirements
