Systems Engineer – AI Medical Devices

Job Description: • 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. Requirements: • 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. Benefits: • An avenue to make a positive impact on people's lives and their health • Growth opportunities are at the heart of our people journey, we’re doing big things with bright minds - there is no single path to success, it can be shaped along the way • Building strong relationships is at the core of everything we do - our team gets together each week to connect, share, and socialize Apply tot his job