Systems Risk Engineer - Software & Electrical Safety …, Burnaby

Your opportunity By joining the Kardium team, you can help make a difference in the lives of millions around the world. We have developed a ground‑breaking medical device for the diagnosis and treatment of the most common heart rhythm disorder, atrial fibrillation – which can cause stroke, heart failure, and other heart‑related complications. To achieve this, we have brought to market the Globe® Pulsed Field System, a product with strong, unique, and customer‑valued differentiators versus other solutions on the market. We have built connections with key opinion leaders who are already using the Globe System and are helping to tell our story. We are now preparing for our upcoming commercial launch, an exciting and significant milestone in our journey to bring this ground‑breaking technology to patients. You will be an integral part of the Quality Engineering team, collaborating intensively with the Software Development and Testing, and Electrical Engineering teams. Your daily activities will center around supporting and influencing software and electrical product design and development through system‑level risk management activities. Critical to the success of this function are strong analytical skills and a high attention to detail and rigor in software and electrical design analysis, ensuring all regulatory standards are met. This opportunity is a hybrid work arrangement located in Burnaby, BC. Your responsibilities will be to: Create and maintain design and process FMEA documents for software and electrical systems. Work closely with the software and electrical engineering teams to understand the product in depth, document associated safety risks and identify appropriate risk mitigations. Perform impact analysis of software and electrical design changes and new features on the safety and security risk profile of the device. Perform impact analysis of system design changes and new features on the risk profile of the device in accordance with ISO 60601. Analyze software bugs for impact on the safety and security profile of the device. Collaborate with regulatory affairs team to prepare risk documentation for regulatory submissions. What you bring to the team Our Kardium team is smart, creative, and passionate about developing cutting‑edge medical devices. We work in a collaborative environment based on trust and respect. You will be successful in this role because you possess these attributes: Minimum Bachelor’s or higher degree in Software Engineering, Electrical Engineering, Biomedical Engineering or Computer Science with a minimum of 4 years of experience in conducting software architecture design, electrical system design, or a combination of both. Minimum of 3 years’ experience in a regulated industry, preferably in medical devices or biotechnology. Working knowledge of risk management and medical device standards (e.g., ISO 14971, ISO 60601, IEC 62304). Hands‑on experience with risk management tools (Failure Mode and Effect Analysis, Hazard Analysis, etc.). Experience working on regulatory submissions for regulatory/notified bodies. Excellent written and verbal communication and technical documentation skills. Solid analytical and interpersonal skills. Excellent ability to come up to speed quickly on complex subject matter across multiple disciplines. Compensation Base salary: CAD $94,000 – 120,000 annually (salary range adjustable based on qualifications and experience) Additional RRSP contribution of 5% Stock option plan as a permanent employee Your Benefits & Well‑being Comprehensive medical and dental coverage for all permanent employees, effective as Day 1 with no waiting period. Registered Retirement Savings Plans (RRSP) contribution of 5%. Work‑day flexibility with 3 personal days per year. Support for you and your dependents' overall well‑being. Career progression and learning support. Professional membership support. Family building perks: top‑up for maternity leave and adoptive leave. Coverage for fertility drug treatment. Additional 3rd‑party benefits and wellness programs. We encourage applications from all qualified candidates who represent the full diversity of all communities. As part of your application, please note if you require any accommodations for the recruitment process (alternate formats of materials, accessible meeting rooms, or other needs). The recruitment team will provide appropriate accommodations. #J-18808-Ljbffr Apply on Kit Job: kitjob.ca/job/2pqdwt