Systems Verification & Validation Engineer
PulseMedica is searching for a Systems Verification & Validation (V&V) Engineer to join a collaborative team dedicated to transforming the future of ophthalmic care. Reporting to our Systems Engineering Team Lead, this person will be responsible for developing and executing system-level verification and validation activities for PulseMedica's innovative ophthalmic imaging and laser treatment platform.
This hands-on role will provide exposure to multidisciplinary product development, including systems engineering, machine learning, software, optics, clinical research, quality assurance, and regulatory affairs. As a key contributor, you will help ensure our medical technologies meet the highest standards of safety, quality, performance, and regulatory compliance.
The Opportunity
The successful candidate will lead and support system-level verification and validation efforts, helping ensure product requirements, safety objectives, and regulatory expectations are met throughout the product development lifecycle.
You will play a central role in designing test strategies, coordinating validation activities, supporting regulatory submissions, and continuously improving our quality and development processes in a fast-paced startup environment.
The person will be responsible for:
- Develop and execute system-level Verification & Validation (V&V) strategies, test plans, protocols, and reports to ensure product performance, safety, and regulatory compliance.
- Plan, coordinate, and lead system testing activities, including functional, performance, safety, integration, and usability evaluations across bench-top, ex-vivo, and animal model environments.
- Collaborate with engineering, quality, regulatory, clinical, and product teams to ensure complete traceability from user needs and system requirements through verification and validation activities.
- Analyze, document, and communicate test results, non-conformances, deviations, and root cause investigations while supporting corrective and preventive actions.
- Support risk management activities, including hazard identification, risk assessments, mitigation development, and verification of risk controls.
- Contribute to regulatory submissions and quality system documentation by preparing clear, accurate, and compliant technical reports and records.
- Support usability engineering and human factors activities to ensure end-user needs are effectively incorporated into product development and testing.
- Identify project risks, recommend mitigation strategies, and support the achievement of key technical, regulatory, and business milestones.
- Research, develop, and implement improvements to V&V methodologies, testing infrastructure, and engineering best practices to support company growth and product development.
- Serve as a technical resource for validation activities, providing guidance and support to cross-functional team members when required.
- Support intellectual property activities, industry conferences, marketing initiatives, fundraising events, and other company-wide objectives as needed.
- Demonstrate strong communication, critical thinking, and problem-solving skills while contributing to a collaborative, innovative startup environment.
Qualifications
- Bachelor's, Master's, or PhD in Systems Engineering, Biomedical Engineering, Mechanical Engineering, Electrical Engineering, Software Engineering, or a related discipline.
- 3+ years of experience in verification, validation, systems engineering, quality engineering, or medical device development.
- Experience working within regulated environments, preferably medical devices.
- Experience developing and executing test protocols and generating technical reports.
- Familiarity with risk management methodologies and systems engineering principles.
- Knowledge of regulatory frameworks such as FDA Quality System Regulation, Health Canada requirements, and ISO 13485 is considered an asset.
- Experience with requirements management and traceability tools is considered an asset.
- Experience supporting machine learning or software-enabled medical device development is an asset.
What you bring
- Strong understanding of systems engineering and product development lifecycles.
- Excellent analytical, troubleshooting, and problem-solving abilities.
- Strong attention to detail and commitment to quality.
- Exceptional written and verbal communication skills.
- Ability to communicate complex technical concepts to diverse audiences.
- Strong organizational and project management skills.
- Ability to manage multiple priorities in a fast-paced startup environment.
- Experience working effectively in multidisciplinary teams.
- Self-motivated with a proactive and collaborative mindset.
- High degree of professionalism, integrity, and accountability.
- Proficiency with Microsoft Office and technical documentation tools.
- Passion for developing technologies that improve patient outcomes and quality of life.
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.