System Engineer

19 hours ago

Pune, Maharashtra, India Tata Elxsi Full time

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

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