Systems Engineer (Hybrid)
About The Position
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. Kardium’s mission is to deliver the best treatment for atrial fibrillation. To achieve this, we have developed The Globe® Pulsed Field System – a revolutionary solution designed by our world-class technical team. The Globe System offers strong, unique, and customer-valued advantages over other treatments on the market, and leading physicians are already using it and helping to share our story. We have obtained FDA approval and officially begun the commercial launch of the Globe® Pulsed Field System. This is a pivotal and exciting time in our journey, as we bring this life-changing technology to patients! In this role, you will be joining the Systems Engineering – Implementation team, and collaborate with colleagues in Engineering, Testing, Regulatory Affairs, Risk Management and Clinical Development Engineering teams. As a Systems Engineer, you will be working across the technical, regulatory, human factors, testing, and risk management domains. Your daily activities will centre around various aspects of design controls. Please note, this opportunity is a hybrid work arrangement, located in Burnaby, BC.
Requirements
- Bachelor's degree in engineering
- Understanding of technical mechanical concepts and medical systems
- Minimum 4 years’ experience with medical device design controls and quality management systems.
- Practical knowledge of medical device regulatory requirements and standards such as ISO 13485 and ISO 14971
- Excellent written and verbal communication and technical documentation skills
- Strong analytical and interpersonal skills
- Ability to work as part of a team and independently
- High degree of drive and motivation
Responsibilities
- Managing product and system design requirements with input from risk management, regulatory affairs, design, and test engineering teams
- Ensuring design controls are appropriately applied and documented during product development, and carrying out design transfer activities to manufacturing requirements
- Supporting change control processes for mechanical hardware
- Supporting the risk management process by developing requirements that mitigate system risks
- Investigating issues identified during testing and clinical use of devices, and as a subject matter expert, driving resolution with interdisciplinary teams
- Becoming familiar with and staying current on relevant medical device standards and regulations
Benefits
- 5% Retirement Savings Plan contribution
- Stock option plan
- Comprehensive medical & dental coverage
- Flexible work environment for daily working hours
- 3 personal days per year
- Support for overall well-being (and dependents)
- Top up for maternity leave, adoptive leave, and parental leave for non-birthing parents
- Benefit coverage for fertility drug treatment
- Career progression and learning support
- Professional membership support
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Mid Level
