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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 laserbased treatment platform. This role focuses on systemlevel 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 worldclass team of scientists, engineers, and clinicians to revolutionize ophthalmic care. Our platform integrates realtime computer vision, deep learning, 3D imaging, and highprecision laser surgery to deliver nextgeneration 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 a Great Place to Work for 4 consecutive years, we've built a culture where innovation thrives and multidisciplinary teams solve complex challenges at speed. Our technology blends realtime computer vision, deep learning, and 3D imaging with highprecision laser systems to create new treatment solutions to prevent vision loss. By uniting cuttingedge 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 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 systemlevel test protocols, analyze requirements, and ensure that risk controls and design outputs are thoroughly verified.

The ideal candidate is detailoriented, technically curious, and comfortable working across software, hardware, optics, and clinical workflows in a regulated environment.

Key Responsibilities

• Develop, execute, and maintain systemlevel and softwarelevel 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 auditready 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 systemlevel 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 623661, or equivalent frameworks.
• Strong analytical, problem-solving, and communication skills.
• Ability to work independently and collaboratively in a fastpaced environment.

Preferred Qualifications

• Experience verifying medical devices, imaging systems, robotics, laser systems, or electromechanical systems.
• Experience with riskbased testing and verification of risk control measures.
• Experience validating software tools used in development, testing, manufacturing, or clinical workflows.
• Handson 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/MLenabled software, computer vision, or realtime 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!

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.