Systems Engineer

• Support the design, development and validation of SaMD systems in accordance with FDA, Health Canada and ISO standards.
• Work closely with ML scientists, software developers, clinical experts and regulatory teams to ensure system-level alignment across technical and clinical requirements.
• Assist in defining, documenting and maintaining scalable, secure, and compliant system architectures for AI-enabled MRI software.
• Define and document system requirements, functional specifications and validation procedures ensuring full traceability throughout the design control process.
• Conduct system-level risk assessments and manage risk mitigation activities tied to performance, safety and usability.
• Contribute to the planning and execution of verification and validation (V&V) testing, ensuring traceability from requirements to performance metrics.
• Provide technical documentation and evidence to support regulatory submissions (such as 510(k), IDE, Health Canada Class II) and audits.
• Assist with sustaining engineering, change control and performance monitoring activities in alignment with Good Machine Learning Practice.

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