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Urgent! System Engineer Job Opening In Pune – Now Hiring Confidential

System Engineer



Job description

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


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


Required Skill Profession

Engineers



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