Systems Engineer – AI Medical Devices (Contractor)

Prenuvo is seeking a collaborative Systems Engineer to support the design, integration and validation of AI-driven diagnostic software systems. The role involves ensuring that SaMD products meet global regulatory standards while delivering clinical-grade performance and reliability.

Requirements

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

Benefits

• Growth opportunities
• Building strong relationships
• An avenue to make a positive impact on people's lives and their health