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Added 2 days ago
Maintenance Planner/Scheduler
Sinopec Canada Energy Ltd.
Grande Prairie, AB
…scheduling of maintenance of Sinopec’s rotating equipment and E&I systems in the Grande Prairie and Drayton Valley area. This position will be based at either Sinopec Canada’s Grande…
Added 2 days ago
C
Software Engineer, Design Systems & AI Tooling
Citi
Mississauga, ON
- Full-time
…build, scale, and integrate the next generation of AI-powered developer tools, design systems, and data…
Added 2 days ago
JT
Employment Counsellor, Job ID #8173
JVS Toronto
Toronto, ON
- Full-time
Computer literate, proficient in Microsoft Office; ability to learn systems used by the agency (e.g. Salesforce)
Added 2 days ago
K
Senior Manager, Technology Operations & Strategy
KPMG
AB · Winnipeg, MB · Saint John, NB · Fredericton, NB · Moncton, NB · Sudbury, ON · Hamilton, ON · Kingston, ON · Sault Ste. Marie, ON · North Bay, ON · London, ON · Windsor, ON · Ottawa, ON · Oakville, ON · Kitchener, ON · Vaughan, ON · Waterloo, ON · Regina, SK · Saskatoon, SK · Langley (District), BC · Prince George, BC · Victoria, BC · Chilliwack, BC · Abbotsford, BC · Vernon, BC · Kamloops, BC · Vancouver, BC · Kelowna, BC · Halifax, NS · St. John's, NL · Calgary, AB · Lethbridge, AB · ON · Toronto, Ontario · Edmonton, Alberta · Kanata, Ontario · Langley, British Columbia
- Full-time
Bachelor's degree in Computer Science, Engineering, Information Systems, Technology Management, Business or a related discipline, or equivalent practical experience
Added 2 days ago
UO
MMA External Partner Relations and Recruitment Advisor
University of Alberta
Edmonton, AB
- Full-time
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Instructional Designer
CAE
Toronto, ON · Montreal, QC · Richmond, BC
- Full-time
Analyze aircraft systems, operational procedures, regulatory frameworks, training requirements, and customer needs to define learning objectives and performance outcomes.
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Senior Analyst, Wealth Data Foundations
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Toronto, ON · FCP
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CE
Fence Labourer
Cooper Equipment Rentals Limited
Calgary, AB
- Full-time
Valid Class 5 driver’s license required, with a clean or satisfactory driver’s abstract (no more than 3 demerit points)
Added 2 days ago
B
Director, Technology
BDC
Montreal, QC
- Full-time
Integrate BDC systems only when necessary, using lightweight connections.
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Oracle EBS Finance Specialist
Standard Aero
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Degree or diploma in Accounting, Finance, Business Administration, Information Systems, or a related field, or equivalent work experience
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EV
Administrative Assistant, Recruitment (Temporary)
Elk Valley Resources
Sparwood, BC
- $55,800 CAD / year
- Full-time
Added 2 days ago
DB
System Engineer
Deep Breathe
London, ON
- Full-time
…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…
Added 2 days ago
S
Digital & Telecom System Architect
Scalian
Montreal, QC
- Full-time
We are looking for a Digital & Telecommunications Systems Architect to support the design and development of next-generation satellite communication systems.
Added 2 days ago
ES
DevOps Engineer
Epsilon Solutions Ltd.
Montreal, QC
- Contract
5+ years of experience supporting Linux and/or Windows systems, including troubleshooting, shell scripting, and automation.
Added 2 days ago
LD
Drafting Manager
Laebon Developments Ltd.
Red Deer, AB
- Full-time
· Working knowledge of residential structural, mechanical (HVAC), and electrical systems.
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HR
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Horizon Recruitment Inc
Vancouver, BC
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Experience in roofing, cladding, or building envelope systems preferred
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I
Manager, Art Direction (14-month contract)
Indigo
Toronto, ON
- $90,000 to $120,000 CAD / year
- Contract
We Will Be Systems Thinking, Data Driven and AI enabled
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PG
Fullstack Developer
Pacer Group
Mississauga, ON
- $120,000 to $130,000 CAD / year
- Full-time
Experience with messaging systems such as JMS/Kafka/Solace/RabbitMQ/ActiveMQ
Added 2 days ago
NS
Electrical /Instrumentation & Control (I&C) Designer
Next Structural Integrity Inc.
Toronto, ON · Greater Toronto Area, Canada
- $85 to $110 CAD / hour
- Part-time
Design and analyze electrical power distribution systems for nuclear and industrial facilities.
Added 2 days ago
GR
Application Analyst
GO ROCK IT
Toronto, ON · Greater Toronto Area, Canada
- Full-time
Develop and maintain integrations between internal and external systems.
Added 2 days ago
BV
Business Development Officer - Sales & Workforce Solutions
Bow Valley College
Calgary, AB · Greater Calgary Metropolitan Area
- Full-time
…improvement of sales processes, client engagement strategies, and systems that support the effective growth of non-government revenue. The position maintains accurate client records, sales…
Added 2 days ago
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SCM Advisor – Digital IT Contracts
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Calgary, AB
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Dynamics 365 & Power Platform Specialist (Calgary South)
Trail Appliances AB/SK
Calgary, AB
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…applications, automations, and integrations with enterprise…
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Analyste comptable / Accounting Analyst
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Baie-D'Urfé, QC
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Added 2 days ago
AC
Specialist, Data and AI - AI Systems Integrator
Air Canada
Toronto, ON · Dorval, QC
- Full-time
The Data & AI Specialist (AI Systems Integrator) acts as a technical steward within Air Canada’s enterprise AI ecosystem. The role is accountable for ensuring that AI workloads, platforms,…

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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Work requirements

Jobs in Canada