Senior Systems Specialist

2 days ago

Thoothukudi, Tamil Nadu, India beBeeSystemEngineering Full time ₹ 80,00,000 - ₹ 2,00,00,000
System Engineering Expertise

We collaborate with leading medical device OEMs and technology companies for market research, human factor engineering, hardware and software development, verification & validation, and regulatory standards compliance.

Our Medical Device and Healthcare practice is ISO 13485 certified.

Key Responsibilities:

  • Proficiency in systems engineering and requirements management.
  • Effective communication of technical system requirements to cross-functional teams.
  • Good understanding of software and hardware systems architecture.
  • Writing technical system requirements and updating in Doors (Requirement Management Tool).
  • Driving traceability between TSR to TSSR's and Risk files.
  • Knowledge of ISO 14971, risk management process.
  • Regulatory standards identification and update of System documents.
  • Basic knowledge of Electronics / Electrical / Mechanical and SW Design.
  • Verification of Medical devices at system level - Test case writing, review, and execution.
  • Preparation of 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 work with cross-functional teams.
  • Coordination with External test labs for testing of applicable standards/requirements.

Requirements:

  • 4+ years of experience in the field.

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