Job Title

Opportunity By joining the Kardium team, you can help make a difference in the lives of millions around the world. We have developed a groundbreaking medical device for the diagnosis and treatment of the most common heart rhythm disorder, atrial fibrillation which can cause stroke, heart failure, and other heartrelated complications. Kardiums mission is to deliver the best treatment for atrial fibrillation. To achieve this, we have developed The Globe Pulsed Field System a product with strong, unique, and customervalued 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. This is an exciting and significant milestone in our journey to bring this groundbreaking technology to patients. You will be an integral part of the Quality Engineering team but 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 systemlevel riskmanagement activities. Critical to the success of this function are strong analytical skills and your high attention to detail and rigor in software and electrical design analysis and ensuring all regulatory standards are met. This opportunity is a hybrid work arrangement, located in Burnaby, BC. Responsibilities 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. Qualifications Minimum Bachelors or higher degree in Software Engineering, Electrical Engineering, Biomedical Engineering or Computer Science with 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). Handson experience with risk management tools (Failure Mode and Effect Analysis, Hazard Analysis, etc.). Experience working on regulatory submissions for regulatory/notified bodies. Excellent written & verbal communication and technical documentation skills. Strong analytical and interpersonal skills. Excellent ability to come up to speed quickly on complex subject matter across multiple disciplines. Compensation We offer a total cash compensation range (base salary + 5% RRSP contribution) as of the time of this posting. Pay offered will be determined based on numerous relevant business and candidate factors including, for example, education, qualifications, certifications, experience, skills, and business or organizational needs. For candidates with more or less experience than listed above, the pay range will be adjusted. As a permanent employee, you will also participate in Kardiums stock option plan. Salary range: $94,000 120,000 CAD annually. Benefits & Wellbeing Comprehensive medical and dental coverage for all permanent employees effective as of Day 1, with no waiting period. Workday flexibility additionally, we provide 3 personal days per year. Support for you and your dependents overall wellbeing. Career progression and learning support. Professional membership support. Family building we provide topup for both maternity leave & adoptive leave. Employees can also enroll in benefit coverage for fertility drug treatment. Life at Kardium: our purpose, people, and culture. Life at Kardium At Kardium, we embrace diversity of background, experience, and perspective and are committed to inclusion and equity at every level. We encourage applications from all qualified candidates who represent the full diversity of all communities. We collaborate with Employee Resource Groups (ERGs), volunteerled groups who share a common dimension of diversity and provide support, education, and other opportunities across Kardium. Examples of our ERGs include Women ERG, Pride ERG, Race Ethnicity & Cultural Heritage (REACH) ERG, Truth & Reconciliation ERG, Persian Community ERG, Chinese ERG, Barangay Kardium (Filipino) ERG, Brazilian ERG, and Irish ERG. As part of your application, we encourage you to note if you require an accommodation for the recruitment process (including alternate formats of materials, accessible meeting rooms or other accommodations). There will be an optional section in the application form where you can provide this information to the recruitment team. And our employees think we are great too check out Glassdoor to learn more! #J-18808-Ljbffr