Systems Engineer

About Deep Breathe

Deep Breathe builds AI-enabled software that helps clinicians use ultrasound with confidence at the bedside, wherever care happens. Founded in London, Ontario in 2021, we have 2 FDA-cleared AI-enabled software devices. Our newest innovation is designed to bring AI-enabled detection of life-threatening injuries to the point of care in hospital, pre-hospital (EMS) and military settings. We are a small team across engineering, machine learning, clinical research, regulatory, quality and operations, working on a mission to democratize diagnostics.

About the role

Our software is built to put AI-enabled ultrasound in the hands of trauma teams, paramedics and military medics, and it has to earn their trust before it ever reaches a patient. As our Systems Engineer, you lead the design controls, risk management and verification work that carry our devices through regulatory submissions into release. You'll start by taking our current iOS Software as a Medical Device (IEC 62304 Class C) through its FDA 510(k) and Health Canada submissions, then bring that same rigour to each product that follows.

Working alongside the Regulatory Affairs Lead and embedded with our software and ML developers, you'll work across regulatory, engineering, data science, quality and leadership to turn fast-moving development into traceable, submission-ready records. You'll also follow, maintain and improve our quality management system (QMS) with our Quality Manager.

If you want your work to influence how a first-of-its-kind AI device is built, tested and trusted, we'd like to hear from you.

Key responsibilities

Design Controls

• Author and maintain the design history file, including user needs, requirements, design specifications and their traceability to risk, verification and validation in the eQMS
• Collaborate with engineering to author and review software verification plans, protocols and reports, ensuring traceability to controlled software, ML model and dataset versions
• Coordinate and participate in design reviews

Risk Management, Usability, and Cybersecurity

• Participate in ISO 14971 risk analysis, including hazard analysis and the identification of software, ML and cybersecurity failure modes
• Define and verify risk controls, and maintain the risk management file
• Support usability engineering under IEC 62366-1, including use-related risk analysis
• Generate, assess and document software bills of materials (SBOMs), software of unknown provenance (SOUP), unresolved software anomalies and common vulnerabilities and exposures (CVEs)

Quality Management System

• Follow, maintain and improve QMS procedures with the Quality Manager
• Support change control across the QMS, including design and risk impact assessments
• Plan and document validation of software tools impacting the quality system
• Support management reviews and participate in internal and external audits, including MDSAP and ISO 13485

Regulatory and Post-Market Support

• Translate engineering efforts into submission-ready evidence, and regulatory needs into engineering tasks
• Support software release and design transfer, including verification of maintenance releases and updates
• Provide technical input to post-market activities such as complaints, nonconformities, CAPAs and cybersecurity monitoring

Qualifications

• 3+ years in systems, quality or verification engineering for regulated medical devices, ideally software as a medical device
• Bachelor's degree in engineering (biomedical, systems, software, electrical or similar) or a related technical field
• Experience applying design controls under ISO 13485, including design elements, traceability, design reviews, change control, and verification and validation documentation
• Experience applying ISO 14971 risk management, from hazard analysis through risk control verification
• Working knowledge of the IEC 62304 software lifecycle
• Comfortable reading code and test suites well enough to judge what a test actually verifies
• Clear, concise technical writing, including testable, unambiguous requirements
• Able to work independently in a small company: you take direction from regulatory, negotiate with engineering and push back with evidence

Preferred

• Has used an eQMS (Greenlight Guru Ultra or similar) and maintained and improved quality procedures alongside a Quality Manager or QMS consultants
• Has contributed to a 510(k) submission or Health Canada medical device licence application, ideally for an AI/ML device
• Familiar with standards and FDA guidance on cybersecurity, usability and human factors engineering, AI-enabled device software functions and predetermined change control plans
• Familiar with scripting (Python or similar) for data and documentation work, and with Swift/iOS
• Familiar with cloud data storage (GCP, AWS or Azure) and command-line tooling
• Knowledge of ML development workflows: datasets, model versioning, train/test independence and operating thresholds
• Background in ultrasound, medical imaging or electronic health record integration

Tools and Standards You’ll Use

• Standards: ISO 13485, ISO 14971, IEC 62304 (Class C), IEC 62366-1
• FDA: 510(k), QMSR (21 CFR 820), 524B cybersecurity, 21 CFR 892.2050 / 892.2060
• Health Canada: Medical Devices Regulations (SOR/98-282), medical device licence, MDSAP
• eQMS: Greenlight Guru Ultra
• Security and SBOM: SPDX / CycloneDX, Trivy, OSV-Scanner
• Data and scripting: Python, shell, Google Cloud Storage
• Collaboration and AI: Claude, Google Workspace, Slack

Why Join Deep Breathe

• Own the design history of AI-enabled medical devices through submission, release and beyond
• Work directly with the software and machine learning engineers, clinicians and regulatory staff building the innovation
• Help bring your work to trauma, EMS and military teams in the field

How to apply

Apply with the Apply button on this posting or at deepbreathe.ai/careers. If you have trouble submitting, email [email protected].

Deep Breathe welcomes applications from all qualified candidates. We provide accommodations for applicants with disabilities throughout the hiring process, in line with the Accessibility for Ontarians with Disabilities Act (AODA). Let us know if you need one.