Job Description :
Job information Product Development Engineer (Hybrid) from the Company Kardium Inc., this latest Product Development Engineer (Hybrid) job vacancy is located in the city Burnaby, BC. This latest job opening is open to job seekers who have the latest education / graduate . Job Vacancies in this Engineering field have been opened and published up to the specified time.
Job Responsibility:
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. Kardium's mission is to deliver the best treatment for atrial fibrillation. To achieve this, we have developed The Globe® Pulsed Field System - we have a fantastic technical team that has developed 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 have now completed our pivotal clinical study and our focus is on regulatory approvals and commercial launch. This is an exciting and significant milestone in our journey to bring this ground-breaking 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 Engineering teams. Meaningful work you will be a part of As a Product Development Engineer within the Systems Engineering team, you will be working across the technical, regulatory, usability, testing, and risk management domains. Your daily activities will centre around product development and requirements management. Your core responsibilities will include:- Driving product development activities for new components within complex medical systems
- Managing product and system design requirements with input from risk management, regulatory affairs, design, and test engineering teams
- Communicating with internal teams and external vendors
- 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 and electrical 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
- Bachelor's degree in engineering
- 5+ years' experience in medical device product development
- Understanding of technical mechanical and electrical concepts and medical systems
- 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
- $92,000 - $109,000 (CAD Annually)
More Information
- Salary $92,000 - $109,000
