Become a crucial part of the Systems Engineering team at Kardium in Burnaby, BC. This hybrid position emphasizes collaboration in design controls and regulatory compliance for medical devices.
As a Systems Engineer, you will partner with teams in Engineering, Testing, and Risk Management. Your role focuses on managing system design requirements and supporting regulatory affairs while ensuring appropriate design controls are applied during development. You'll also investigate testing issues and drive solutions alongside interdisciplinary teams.
Key Responsibilities:
• Manage product and systems design with interdisciplinary input
• Ensure design controls are documented during product development
• Support change control for mechanical hardware
• Develop requirements to mitigate system risks
• Investigate testing issues and collaborate to resolve them
Requirements:
• Minimum 4 years in medical device design controls
• Practical knowledge of ISO 13485 and ISO...