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Subject Matter Expert

3 months ago

Pune, Maharashtra, India Saaki Argus & Averil Consulting Full time
Experience - 5+ YearsLocation -PuneMode - Hybrid

Role

- subject matter experts who has Proficiency in systems engineering and requirements management.
KEY Skills Preferred

  • 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/requirementsTool: DOORs, JIRA, ClearQuest, HP ALM, Any PLM tools, Requirement management tools