EnChannel Medical LTD · 12 hours ago
System Engineer, Senior Staff (Systems & Catheters)
Irvine, CA
Full-time
Onsite
Senior Level, Lead/Staff
8+ years expEnChannel Medical is redefining the boundaries of electrophysiology with their next-generation DePolar™ mapping system and integrated NanoAblate™ PFA platform. The System Engineer, Senior Staff (Systems & Catheters) will lead design control activities for cardiac mapping and ablation systems, create mechanical drawings, and ensure compliance with regulatory standards.
BiotechnologyMedicalTherapeutics
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
Qualification
Required
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
Preferred
Experience with Cardiac Ablation catheters and/or electrophysiology mapping system
Company
EnChannel Medical LTD
Founded in 2020 by a team of seasoned electrophysiology innovators from both the United States and China, EnChannel Medical is developing a holistic platform that unifies magnetic-impedance navigation, intracardiac echocardiography, full-chamber 5D action-potential mapping, and mid-voltage (<1000 V) pulsed-field ablation to deliver safe and personalized treatment for patients with atrial fibrillation.
11-50 employees
H1B Sponsorship
EnChannel Medical LTD has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (3)
2024 (1)
Funding
Current Stage
Growth StageTotal Funding
$110.2M2025-04-23Series B· $82.34M
2023-08-01Series A· $27.86M
Leadership Team
Jun Feng
CEO & Co-Founder
Min Zhu
Chief Technology Officer
Recent News
2025-07-01
Company data provided by crunchbase