Senior System Engineer Position

1 week ago

Anantapur, Andhra Pradesh, India beBeeSystemDeveloper Full time ₹ 1,50,00,000 - ₹ 2,00,00,000
System Developer

We offer a challenging role that involves the design and development of complex systems.

Main Responsibilities:
  • Proficiency in systems engineering and requirements management is essential.
  • You will be responsible for understanding technical system requirements and effectively flowing them down into detailed subsystem/unit requirements.
  • A good understanding of software and hardware systems architecture is necessary.
  • You will write technical system requirements, review them with a cross-functional team, and update them in Doors (Requirement Management Tool).
  • Driving traceability between TSR to TSSR's and risk files is crucial.
  • Good knowledge of ISO 14971, risk management process, is required.
  • You should have basic or expert knowledge about regulatory standards and identifying applicable requirements to update system documents.
  • Basic knowledge of FMEA and driving DFMEA system level and down to sub-system level is necessary.
  • Verification of medical devices at the system level - test case writing, review, and execution.
  • Preparing 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 are essential.
  • Collaborating and working with cross-functional teams.
  • Coordinating with external test labs for testing of applicable standards/requirements.

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