Systems and Software Quality Engineer
Are you passionate about ensuring the reliability, safety, and performance of complex hardware–software medical systems? As aSystems and Software Quality Engineer, you will play a critical role in verifying and validating (V&V) PulseMedica’s ophthalmic imaging and laser‑based treatment platform. This role focuses onsystem‑level V&V, requirements analysis, test authoring, and ensuring that our integrated device meets the highest standards of quality and regulatory compliance.
PulseMedica, an Edmonton-based medical device startup, is building a world‑class team of scientists, engineers, and clinicians to revolutionize ophthalmic care. Our platform integrates real‑time computer vision, deep learning, 3D imaging, and high‑precision laser surgery to deliver next‑generation treatment options for eye disease.
About Us
PulseMedica is redefining the landscape of ophthalmic technology by developing breakthrough imaging and laser technologies for ophthalmic disease. Recognized as aGreat Place to Workfor 4 consecutive years, we’ve built a culture where innovation thrives and multidisciplinary teams solve complex challenges at speed. Our technology blends real‑time computer vision, deep learning, and 3D imaging with high‑precision laser systems to create new treatment solutions to prevent vision loss. By uniting cutting‑edge research with scalable engineering, PulseMedica is creating treatment solutions that position the company to be at the forefront of the next generation in eye care.
The Opportunity
We are seeking aSystems and Software Quality Engineerto join our Systems Engineering team. This role is ideal for someone with experience testing and validatingcomplex electromechanical, imaging, or medical device systems, as well assoftware. You will develop and execute verification strategies, author system‑level test protocols, analyze requirements, and ensure that risk controls and design outputs are thoroughly verified.
The ideal candidate is detail‑oriented, technically curious, and comfortable working across software, hardware, optics, and clinical workflows in a regulated environment.
Key Responsibilities
- Develop, execute, and maintainsystem‑level and software‑level V&V strategies, including test plans, protocols, test cases, and test scripts.
- Performfunctional, integration, regression, performance, and system verification testingfor complex HW–SW systems.
- Analyze system, subsystem, and software requirements to ensure clarity, testability, and traceability.
- Build and maintainrequirements traceability matriceslinking requirements, risks, test cases, and results.
- Documentobjective evidencefor verification and validation activities in an audit‑ready manner.
- Identify, document, prioritize, and track defects; verify corrective actions; support root cause analysis.
- Participate in design reviews, providing input on testability, risk mitigation, and compliance.
- Verifyrisk control measuresand support risk management activities in accordance with ISO 14971.
- Support regulatory submissions, audits, and inspections by providing V&V documentation.
- Develop and maintainautomated test scripts or frameworksto improve coverage and repeatability (where applicable).
- Collaborate closely with Software Engineering, Systems Engineering, Clinical Affairs, Product Management, and QA.
- Provide clear reporting on V&V progress, issues, and results.
Qualifications
- Bachelor’s degree inSystems Engineering, Software Engineering, Computer Science, Electrical Engineering, Biomedical Engineering, or a related technical field.
- 3+ years of experiencein verification and validation, systems testing, software testing, or quality engineering.
- Experience working withcomplex hardware–software systems, preferably in amedical device or regulated industry(e.g., aerospace, automotive, robotics, diagnostics).
- Strong understanding ofsystem‑level testing methodologies, including functional, integration, regression, performance, and exploratory testing.
- Experience authoringtest plans, protocols, test cases, and verification reports.
- Familiarity withrequirements management and traceability(e.g., Jama, Polarion, Jira, Azure DevOps, TestRail).
- Experience withtest automationor scripting (Python, JavaScript, C++, or similar).
- Knowledge ofdesign controls, risk management, and regulated product development.
- Familiarity with standards such asISO 13485, ISO 14971, IEC 62304, IEC 62366‑1, or equivalent frameworks.
- Strong analytical, problem-solving, and communication skills.
- Ability to work independently and collaboratively in a fast‑paced environment.
Preferred Qualifications
- Experience verifyingmedical devices, imaging systems, robotics, laser systems, or electromechanical systems.
- Experience withrisk‑based testingand verification of risk control measures.
- Experience validatingsoftware toolsused in development, testing, manufacturing, or clinical workflows.
- Hands‑on experience withbenchtop testing, prototype systems, laboratory equipment, or engineering test setups.
- Experience contributing todesign history files, technical documentation, or regulatory submissions.
- Familiarity withAI/ML‑enabled software, computer vision, or real‑time imaging systems.
Anticipated Start Date:As soon as a suitable candidate is found
Duration: Full Time Permanent (40 hours per week)
Salary:Commensurate to experience and qualifications
Location:Edmonton
What you can expect from PulseMedica:
- Competitive compensation, health, dental and vision benefits and the option to participate in our employee stock option plan
- Free on-site gym (Jackson’s Gym)
- A role that contributes to helping change people’s lives by enhancing their vision
- A unique opportunity to build, grow, and be part of a team that is going to revolutionize a multi-billion dollar industry
- Hybrid work
- Growth Opportunities
- Monthly team social events
- Working for a company that was recentlyGreat Place to Workcertified!
We believe that diverse teams perform better and that fostering an inclusive work environment is a key part of growing a successful team. We welcome people of diverse backgrounds, experiences, and perspectives to apply for this position.