Join Kardium Inc. as a Systems Engineer and implement groundbreaking medical device solutions. This hybrid role emphasizes design controls and regulatory compliance for advanced atrial fibrillation treatment.
In this Systems Engineering position, you will collaborate with various teams at Kardium to manage product and system design requirements. Your focus will cover risk management, design documentation, and adherence to regulatory standards. The role also involves supporting change control and investigating testing issues, making it pivotal to the product development lifecycle.
Key Responsibilities:
• Manage product design requirements and regulatory compliance
• Ensure design controls are documented and applied
• Support mechanical hardware change control processes
• Develop requirements to mitigate system risks
• Drive resolution of testing and clinical use issues
Requirements:
• 4+ years experience in medical device design controls
• Knowledge of ISO ...