Jobs in Canada

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Added 9 hours ago
Manager, Financial Planning & Analysis
CAA Niagara Talent Management Team
Thorold, ON
Lead CAA Niagara's annual operating and capital budgeting processes across business units and functional areas.
Added 9 hours ago
DW
Digital Fundraising Manager
Doctors Without Borders / Médecins Sans Frontières (MSF) Canada
Montreal, QC · Toronto, ON
- Full-time
Lead the development and execution of digital fundraising campaigns aimed at a full funnel approach including acquisition, renewal and upgrade
Added 9 hours ago
C
Community General Manager II
CIBC
Toronto, ON
- Full-time
You need to be legally eligible to work at the location(s) specified above and, where applicable, must have a valid work or study permit
Added 9 hours ago
UO
MMA External Partner Relations and Recruitment Advisor
University of Alberta
Edmonton, AB
- Full-time
…recruitment practices. A key focus is developing partnerships that lead to internships, capstone projects, guest-speaking opportunities, industry visits, and post-graduation employment.…
Added 9 hours ago
CI
Supervisor (Part Time)
Carters Inc.
Langley (District), BC
- Part-time
If you are a CURRENT Carter’s employee, do not apply via this external application. Search "Browse Jobs" in Workday to apply internally.
Added 9 hours ago
B
Director, Technology
BDC
Montreal, QC
- Full-time
Recruit, lead, and develop the AI development team; establish best practices for delivery, quality, and AI-assisted development.
Added 9 hours ago
EV
Administrative Assistant, Recruitment (Temporary)
Elk Valley Resources
Sparwood, BC
- $55,800 CAD / year
- Full-time
…British Columbia. We are committed to responsible resource development, environmental performance and building strong partnerships with communities and Indigenous…
Added 9 hours ago
DB
System Engineer
Deep Breathe
London, ON
- Full-time
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…
Added 9 hours ago
HI
Legal Counsel
Healthcare Insurance Reciprocal of Canada (HIROC)
Toronto, ON
- Full-time
Insurance Services Policy Development and Revision, Education as to new legal developments.
Added 10 hours ago
J
Project Manager, Commercial Operations (Creative)
Jeeter
Toronto, ON
- $99,360 to $113,160 CAD / year
- Full-time
Helps to manage new workflows for tasks requiring complex development, supporting each phase of the project lifecycle.
Added 10 hours ago
GO
Engineering Project Manager
G2V Optics
Edmonton, AB
- Full-time
We are an agile team that functions on a startup-style culture based on quick learning, honesty and personal development, flexibility, and balance. If you want to be part of a team that's…
Added 10 hours ago
PG
Product Manager - Membership
Perseus Group, Constellation Software
Canada
- Full-time
Act as product lead for AXIS Membership, defining and evolving product direction for key membership processes like new memberships, renewals, upgrades, transfers and digital self-service
Added 10 hours ago
JI
Civil Engineering Student-Summer 2027
J.D. Irving, Limited
Saint John, NB
- Full-time
Development opportunities to prepare you for leadership roles in the future.
Added 10 hours ago
JI
Branch Manager - Head Office (Saint John N.B)
J.D. Irving, Limited
Saint John, NB
- Full-time
…sustainable business growth. We are seeking a Branch Manager to lead our Saint John branch operations, one of the largest and most complex branches in our network. Reporting to the Director…
Added 10 hours ago
LC
Grocery Department Manager in Training
Loblaw Companies Limited
Calgary, AB
- Full-time
Lead, coach and motivate colleagues to improve productivity, engagement and retention
Added 10 hours ago
4
Jr Administrative Assistant
49North
Ottawa, ON · Kanata, ON
- Full-time
Take the lead on new employee on-boarding (equipment/ access requests and office allocation)
Added 10 hours ago
IM
Director, Risk and Performance Technology
Investment Management Corporation of Ontario (IMCO)
Toronto, ON
- Full-time
Lead application upgrades, enhancements, integrations, modernization initiatives, and platform rationalization activities.
Added 10 hours ago
M-
Chief Fire Officer
MFO - Multinational Force & Observers
Ottawa, ON
- $94,000 USD / year
- Full-time
You will lead four Fire Watch Managers and two Fire Station Managers within a multinational team. This full-time, non-accompanied international staff position is based at South Camp, Sharm…
Added 10 hours ago
Manager, Health & Safety - Project Delivery
Trans Mountain
Calgary, AB
Must have a valid Class 5 driver’s license
Added 10 hours ago
E
Director of Care (DOC) - Full Time (FT) - Hillcrest Place
Extendicare
Brandon, MB
- Full-time
Cultivate - lead the resident care team, providing day-to-day guidance and fostering a positive work environment that encourages collaboration, accountability, drives high performance and…
Added 10 hours ago
Strategic Planning Analyst III - Program Manager, Portfolio Management and Governance
City of Edmonton
AB
Positions with supervisory responsibilities must have two (2) years progressively responsible supervisory experience
Added 10 hours ago
Strategic Planning Analyst III - Value Realization & Strategic Investment
City of Edmonton
AB
Positions with supervisory responsibilities must have two (2) years progressively responsible supervisory experience
Added 10 hours ago
F
Business Development Manager
Financeit
Remote, Canada
- $80,000 to $90,000 CAD / year
- Full-time
- Remote
Financeit is looking for a Business Development Manager to drive new dealer acquisition across Canada's Home Improvement sector. This is a hunting-focused sales role responsible for…
Added 10 hours ago
Leave & Accommodation Business Partner
Molson Coors
Toronto, ON
Lead the accommodation process by reviewing requests, facilitating interactive discussions, evaluating medical documentation, and partnering with stakeholders to identify reasonable…
Added 10 hours ago
Lead Data Center Technician
IREN
Prince George, BC
This role requires availability for a 4-on-4-off rotational shift schedule including day and night shifts · Total package may be inclusive of a night shift premium

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.

Apply on LinkedIn About employer

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