System Engineer

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 :