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Added 5 mins ago
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Analyst, QC Microbiology (12:00 PM - 9:00 PM)
Resilience
Mississauga, ON · CAN - ON - Mississauga - Meadowpine Blvd
- Full-time
Must have the ability to effectively understand, read, write, communicate, and follow instructions in the English language
Added 5 mins ago
R
Analyst, QC Microbiology (6:00 PM - 3:00 AM)
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- Full-time
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Warehouse Operator-Winnipeg, MB
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Added 36 mins ago
DB
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…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…
Added 36 mins ago
TA
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Deep Breathe

System Engineer

London, ON, Canada

Full-time

Apply on LinkedIn About employer

Applications open in a new tab.

Job details

Job type: Full-time
Apply by: Dec 10, 2026
Posting language: English
Posted: Nov 10, 2026

Original job description

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 general@deepbreathe.ai.

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.

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More about this job

Responsibilities

Lead design controls, risk management, and verification activities for AI-enabled medical device software, including maintaining traceable design records and supporting FDA and Health Canada submissions. Maintain and improve the quality management system, support software releases and audits, and contribute to post-market activities such as complaints, corrective actions, and cybersecurity monitoring.

Requirements

Requires at least three years of systems, quality, or verification engineering experience in regulated medical devices, a relevant bachelor's degree, and practical experience with ISO 13485 design controls, ISO 14971 risk management, and the IEC 62304 software lifecycle. Candidates should be able to review code and tests, write clear technical requirements, and work independently across regulatory and engineering teams.

Skills

Design Controls
Risk Management
Medical Device Software Verification
Design History File
ISO 13485
ISO 14971
IEC 62304
IEC 62366-1
Software as a Medical Device
FDA 510(k) Submissions
Health Canada Medical Device Licensing
Quality Management Systems
Requirements Traceability
Cybersecurity Risk Assessment
Software Bill of Materials
Technical Writing

Visa sponsorship

Not detected in the job text

Keywords

Design Controls
Design History File
Risk Management
ISO 13485
ISO 14971
IEC 62304
IEC 62366-1
FDA 510(k)
Health Canada Medical Device Licence
MDSAP
QMSR
21 CFR 820
524B Cybersecurity
Software as a Medical Device
AI/ML Medical Devices
Verification and Validation
Requirements Traceability
eQMS
Greenlight Guru Ultra
Software Bill of Materials
SPDX
CycloneDX
Trivy
OSV-Scanner
Python
Swift
iOS
Google Cloud Storage
Usability Engineering
Cybersecurity Monitoring

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