System Engineer

3 weeks ago

Pune, India foundit Full time

Key Job Responsibilities:


  • Manage and maintain system-level requirements using systems engineering principles and requirements management tools.
  • Understand and decompose technical system requirements into detailed subsystem/unit requirements.
  • Contribute to and review software and hardware systems architecture.
  • Write and review technical system requirements with cross-functional teams; update and maintain these in DOORS.
  • Drive traceability from technical system requirements to technical subsystem requirements and associated risk files.
  • Apply knowledge of ISO 14971 to drive the risk management process for medical devices.
  • Identify applicable regulatory standards and ensure documentation meets compliance needs.
  • Possess foundational understanding of electronics, electrical, mechanical, and software design concepts.
  • Contribute to system-level DFMEA and cascade findings to subsystem-level FMEA.
  • Perform verification and validation of medical devices at the system level, including test case creation, reviews, and execution.
  • Prepare high-quality documentation for regulatory submissions.
  • Support and understand system integration planning, testing, and reporting.
  • Coordinate with external testing labs to ensure compliance with required standards and certifications.
  • Work collaboratively with cross-functional engineering and quality teams to ensure project success.
  • Maintain clear and effective documentation and reporting throughout the development lifecycle.


Preferred Behavioral Skills:


  • Agility: Drive fast and effective decision-making and actions
  • Confidence to take on the world: Think big and embrace challenges
  • Transparency: Build trust by sharing information openly
  • Improve Collaboration: Foster teamwork to drive collective success
  • Ownership: Take responsibility and deliver results effectively
  • Nurture Learning & Growth: Support the continuous development of team capabilities

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