Titre du poste ou emplacement

Systems Engineer, Verification & Validation

Pulse Medica - 2 emplois

Edmonton, AB

Publié il y a 4 jours

Détails de l'emploi :

Temps plein
Expérimenté

Systems Engineer, Verification & Validation

PulseMedica is searching for a Systems Engineer Verification & Validation (V&V) (or Systems Specialist, V&V) to join a collaborative team dedicated to transforming the future of ophthalmic care. Reporting to our Systems Engineering Team Lead, this person will ensure the safety and correct functioning of PulseMedica's innovative platform and be responsible for taking a systems engineering approach to developing and leading system-level verification and validation activities.

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.

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 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

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. As an integral member of the Systems Engineering team, you will also have an opportunity to support a number of other activities that are owned by the team.

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.
  • Lead the development and management of innovative designs for test vessels that are vital for V&V activities
  • 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.
  • Experience with Optical systems is considered an asset.
  • Experience with requirements management and traceability tools is considered an asset.
  • 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.

What you bring

  • Passion for developing high technologies that improve patient outcomes and quality of life.
  • Self-motivated with a proactive and collaborative mindset.
  • Strong attention to detail and commitment to quality.
  • High degree of professionalism, integrity, and accountability.
  • Ability to manage multiple priorities in a fast-paced startup environment.
  • Ability to communicate complex technical concepts to diverse audiences.
  • Excellent analytical, troubleshooting, and problem-solving abilities.
  • Proficient at translating clinical needs into objective test methodologies
  • Experience working effectively in multidisciplinary teams.
  • Exceptional written and verbal communication skills.
  • Strong understanding of systems engineering and product development lifecycles.
  • Strong organizational and project management skills.

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.

Partager un emploi :

Foire aux questions