Systems and Software Quality Engineer
Are you passionate about ensuring the reliability, safety, and performance of complex hardware-software medical systems? As a Systems 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 on system-level V&V, requirements analysis, test authoring, and ensuring that our integrated device meets the highest standards of quality and regulatory compliance.
The Opportunity
We are seeking a Systems and Software Quality Engineer to join our Systems Engineering team. This role is ideal for someone with experience testing and validating complex electromechanical, imaging, or medical device systems, as well as software. 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 maintain system-level and software-level V&V strategies, including test plans, protocols, test cases, and test scripts.
- Perform functional, integration, regression, performance, and system verification testing for complex HW-SW systems.
- Analyze system, subsystem, and software requirements to ensure clarity, testability, and traceability.
- Build and maintain requirements traceability matrices linking requirements, risks, test cases, and results.
- Document objective evidence for 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.
- Verify risk control measures and support risk management activities in accordance with ISO 14971.
- Support regulatory submissions, audits, and inspections by providing V&V documentation.
- Develop and maintain automated test scripts or frameworks to 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 in Systems Engineering, Software Engineering, Computer Science, Electrical Engineering, Biomedical Engineering, or a related technical field.
- 3+ years of experience in verification and validation, systems testing, software testing, or quality engineering.
- Experience working with complex hardware-software systems, preferably in a medical device or regulated industry (e.g., aerospace, automotive, robotics, diagnostics).
- Strong understanding of system-level testing methodologies, including functional, integration, regression, performance, and exploratory testing.
- Experience authoring test plans, protocols, test cases, and verification reports.
- Familiarity with requirements management and traceability (e.g., Jama, Polarion, Jira, Azure DevOps, TestRail).
- Experience with test automation or scripting (Python, JavaScript, C++, or similar).
- Knowledge of design controls, risk management, and regulated product development.
- Familiarity with standards such as ISO 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 verifying medical devices, imaging systems, robotics, laser systems, or electromechanical systems.
- Experience with risk-based testing and verification of risk control measures.
- Experience validating software tools used in development, testing, manufacturing, or clinical workflows.
- Hands-on experience with benchtop testing, prototype systems, laboratory equipment, or engineering test setups.
- Experience contributing to design history files, technical documentation, or regulatory submissions.
- Familiarity with AI/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 recently Great Place to Work certified!
