System Engineer

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&aposs 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

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Skills Required

Fmea, Electronics, regulatory standards , Mechanical, Systems engineering, Dfmea, Requirements Management, Electrical, Regulatory Submissions