System Engineer, Senior Staff (Systems & Catheters)

Enchannel Medical • Irvine, CA

1d

About The Position

Enchannel Medical is redefining the boundaries of electrophysiology with our next-generation DePolar™ mapping system, integrated NanoAblate™ PFA platform, and a comprehensive set of mapping and ablation catheters. Driven by our global mission to enhance the quality-of-life of heart rhythm patients, our discerning technology, paired with our passion for innovation, leads to enduring outcomes. Position Overview The System Engineer, Senior Staff (Systems & Catheters) will perform and lead design control activities, including design verification and validation (V&V) and design transfer, for cardiac mapping and ablation systems and catheters. The role is responsible for creating mechanical drawings, authoring documentation, and executing internal design control activities for systems and catheters. This position will also support IEC safety testing at third-party test houses and contribute to the submission and release of QMS documentation. In addition, the role has responsibility for the development of next-generation systems and catheters.

Requirements

• 8-12 years of related technical experience and A Bachelor’s and/or master’s degree in engineering, and/or other technical disciplines.
• Experience in regulated medical devices industries and good understanding of IEC 60601 standards is required.
• Solid skills for system testing, system V&V and authoring QMS documentation are required.
• Solid skills in Mechanical design using SolidWorks or similar software tools.
• Exceptional problem-solving skills and analytic thinking to overcome technical challenges.
• Outstanding communication and interpersonal skills, with the ability to collaborate seamlessly with internal teams and external partners.

Nice To Haves

• Experience with Cardiac Ablation catheters and/or electrophysiology mapping system is a plus.
• Experience with Cardiac Ablation catheters and/or electrophysiology mapping system is a plus.

Responsibilities

• Lead and perform the system and catheter design control, design V&V activities for 3D cardiac mapping and ablation systems as well as catheters.
• Create mechanical drawings and maintain the design history files for the system and catheters.
• Create system and catheter design control documentation.
• Develop the system and catheter design V&V protocols and test methods and release them in the QMS.
• Execute and/or provide guidance for execution of V&V Protocols and author Test Reports for FDA submission.
• Perform system and catheter test, signal processing and data analysis for troubleshooting issues and finding solutions to improve system performance.
• Ensure compliance with QMS procedures and regulatory standards.
• Perform IEC 60601 safety testing at 3rd party test houses to support regulatory submission.
• Collaborate with teams to design, develop, and test next-generation systems.
• Conduct or participate in design reviews for the system and catheter design.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level