Systems Engineer – AI Medical Devices (Contractor)

Minimum of 2 years of experience in medical device development, ideally including Software as a Medical Device (SaMD) or other regulated digital health systems. Knowledge of AI/ML and medical imaging technologies required. Working knowledge of regulatory and quality frameworks, including FDA 21 CFR 820, ISO 13485, IEC 62304, and ISO 14971. Experience supporting design controls, risk management, and verification & validation activities in a regulated environment. Ability to translate complex technical details into clear documentation and communicate effectively with non-technical stakeholders. Bachelor's or Master's degree in Systems Engineering, Biomedical Engineering, Computer Science, or a related discipline.

Support design, development, and validation of SaMD systems in accordance with FDA, Health Canada, and ISO standards. Collaborate with ML scientists, software developers, clinical experts, and regulatory teams. Assist in defining, documenting, and maintaining scalable, secure, and compliant system architectures. Define and document system requirements, functional specifications, and validation procedures. Conduct system-level risk assessments and manage risk mitigation activities. Contribute to the planning and execution of verification and validation (V&V) testing. Provide technical documentation for regulatory submissions and audits. Assist with sustaining engineering, change control, and performance monitoring.