System Engineer
8 hours ago
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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