Position Title: System Engineer, Staff

**Department: R &D, **System Engineering

Reports to: Director, System Engineering

At Enchannel Medical, we’re redefining the boundaries of electrophysiology with our next-generation DePolar™ mapping system and integrated NanoAblate™ PFA platform. 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

We are seeking a System Engineer, Staff to perform and lead Design Verification & Validation (V&V) for 3D Mapping and Ablation systems. This role will be responsible for performing internal system V&V activities, IEC safety tests at 3rd party test houses, and in submitting and releasing QMS documentation. This role also has responsibility for cross-functional teamwork to develop the next generation system.

Duties and Responsibilities

The following are the major responsibilities for this role. Additional responsibilities, tasks, and duties may be required and will be assigned as needed.

• Lead and perform the system design V&V activities for 3D mapping and heart ablation systems.
• Perform IEC 60601 safety testing at 3rd party test houses to support regulatory submission.
• Develop the system 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 submission and release in the QMS.
• Perform system test, signal processing and data analysis for troubleshooting issues and finding solutions to improve the system performance.
• Ensure compliance with QMS procedures and regulatory standards.
• Create system design control documentation.
• Collaborate across teams to design, develop, and test next-generation systems.
• Conduct or participate in system-related design reviews.

Education, Experience and Skills Required

Below are the minimum skills, formal education, certifications or training, and practical experience required to perform the general functions and duties of the role.

• Bachelor’s and/or master’s degree in engineering, and/or other technical disciplines
• Five (5) or more years of related technical experience
• 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 signal processing and data analysis using MATLAB and/or Python.
• Experience with PCB circuit design, FPGA, DSP and firmware development process is a plus.
• Experience with ECG and/or electrophysiology mapping system is a plus.
• 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.