System Engineer

We are seeking a System Engineer that will be responsible for the integration, and verification of an electronic sensing system for a catheter-based class III medical device. The role combines system engineering, electrical engineering, mechanical 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
•  Support interactions with regulatory bodies and certification agencies
• throughout the development process.
• Design and specify test fixtures, jigs, simulators, and measurement systems
• required for development and verification activities.

Requirements

• 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.