System Engineer, Senior Staff (Systems & Catheters)

EnChannel Medical LTD; Irvine (CA); On-site; USD 140,000 - 210,000; Full time

Job summary

EnChannel Medical is seeking a Systems Engineer, Senior Staff to lead design control and V&V for cardiac mapping systems and catheters in a California setting. You will create mechanical drawings, maintain design history, and develop QMS documentation for regulatory submissions.

The ideal candidate has 8–12 years in regulated medical devices, strong SolidWorks skills, and proven problem-solving and cross-functional collaboration abilities to support next-generation systems.

Qualifications

• 8-12 years of related technical experience in engineering.
• Experience in regulated medical devices industries with IEC 60601 standards.
• Solid skills in mechanical design and design control for systems and catheters.
• Experience with system testing, V&V, and QMS documentation.
• Excellent communication and collaboration skills.

Responsibilities

• Lead and perform system and catheter design control and V&V activities for cardiac mapping and ablation systems.
• Create mechanical drawings and maintain design history files.
• Develop design control documentation and V&V protocols for QMS.
• Execute V&V protocols and author test reports for FDA submission.
• Collaborate to design, develop, and test next-generation systems.

Skills

Systems engineering

Regulatory knowledge

Medical device development

SolidWorks

Problem solving

Communication

Education

Bachelor's or Master’s degree in engineering

Tools

SolidWorks

Job description

Engineering

Reports to: Director, Systems Engineering

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 Title: Systems Engineer, Senior Staff

Department: R&D, Systems Engineering

Reports to: Director, Systems Engineering

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.

Duties And 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.

Experience, Education And Skills 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.
• Experience with Cardiac Ablation catheters and/or electrophysiology mapping system is a plus.
• Solid skills for system testing, system V&V and authoring QMS documentation are required.
• Experience with Cardiac Ablation catheters and/or electrophysiology mapping system is a plus.
• 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.

Our pay ranges are determined by role, level, and location. The range displayed on each job posting reflects the minimum and maximum new hire pay for the position located in California. Within the range, individual pay is determined by location, additional factors, including job-related skills, experience, and relevant education or training.

EnChannel Medical is an E-Verify and equal opportunity employer. We believe in hiring a diverse workforce and sustaining an inclusive, people-first culture. We are committed to non-discrimination on any protected basis, such as disability and veteran status, or any basis covered under acceptable law.

Only qualified candidates will be contacted.

JOB CODE: 1382