System Engineer

Position Summary

The System Engineer will be responsible for the integration, and verification of a electronic sensing system for a catheter-based class III medical device. The role combines system engineering, project integration, regulatory compliance, and test method development throughout the product lifecycle, from concept to commercialization.

Key Responsibilities

• Translate clinical, user, and business needs into measurable engineering requirements.
• System integration activities between electrical, mechanical, software, and catheter subsystems.
• Support risk management activities in accordance with applicable medical device standards.
• Work closely with internal teams and external suppliers to ensure successful implementation
• Review electrical/mechanical designs, test results, and verification activities.
• Develop test protocols thorough understanding of applicable standards
• Design and specify test fixtures, jigs, simulators, and measurement systems required for development and verification activities.

Qualifications

• B.Sc. in Electrical Engineering/ Biomedical Engineering/ Systems Engineering, or related discipline.
• M.Sc. – Advantage.
• 5+ years of experience in multidisciplinary medical device development.
• Proven experience in development class III medical device
• Hands-on experience with medical electrical devices.
• Experience with sensing technologies, signal acquisition systems, and electronic medical systems- Advantage
• Experience leading multidisciplinary projects involving hardware, software, mechanical, and system integration teams.
• Experience with catheter-based, cardiovascular, electrophysiology, or structural heart devices – Strong Advantage.
• Experience supporting regulatory submissions and external audits – Advantage.