EnChannel Medical LTD · 1 day ago
Software Engineer, Principal (Test)
Irvine, CA
Full-time
Hybrid
Lead/Staff
11+ years expEnChannel Medical is redefining the boundaries of electrophysiology with their next-generation DePolar™ mapping system and integrated NanoAblate™ PFA platform. The Software Engineer, Principal (Test) will design and implement testing strategies for their 3D cardiac mapping system, ensuring product safety, performance, and reliability through rigorous testing and cross-functional collaboration.
BiotechnologyMedicalTherapeutics
Responsibilities
Design and lead execution of verification and validation test plans, with a focus on complex, high risk, or system level test scenarios, including functional, performance, and stress testing
Establish and uphold principles for scalable test design, including test case structure, traceability, and regulatory submission readiness
Ensure test strategies address clinical workflows and hardware/software/algorithm integration challenges
Collaborate closely with software, algorithms, and hardware teams to perform root-cause investigations for complex, ambiguous, or cross-functional issues
Contribute to automation efforts by partnering with team members, guiding framework architecture decisions, and implementing automated tests to support long-term scalability
Mentor team members and set a high technical bar for test design, investigations, risk analysis, and documentation quality
Author and review test plans, protocols, trace matrices, and reports to ensure alignment with medical standards and regulatory expectations
Influence key requirements, design, and architecture discussions to ensure testability and alignment with test strategies
Continuously evaluate and adopt test setups, tools, and methodologies to improve testing effectiveness, efficiency, and maintainability
Support inspection readiness and regulatory activities including submission documentation and audits
Qualification
Required
11+ years of hands-on experience as either a software test engineer, validation engineer, or in a similar role, with a preferred focus on software validation
Minimum of a Bachelor's degree in a scientific/engineering discipline, or equivalent combination of education and experience. Computer science or electrical engineering degrees are preferred
Demonstrated contributions to 510(k) submissions, audits, or regulatory deliverables, including preparation or review of test documentation
In-depth familiarity with IEC 62304 and software verification and validation processes for medical device software
Track record of designing scalable, risk-based test strategies and producing high-quality documentation
Proven experience in testing complex, integrated systems involving software, hardware, and algorithms
Strong troubleshooting, analytical thinking, and debugging skills in multidisciplinary environments
Experience with test automation tools/frameworks and scripting languages (e.g., Python, C++, etc.)
Strong working knowledge of test management tools such as Jira, TestRail, ADO, or similar platforms
Experience collaborating effectively in Agile development environments
Excellent verbal and written communication skills for cross-functional influence, mentoring, and high-quality documentation
Ability to manage a significant technical workload, prioritize effectively, and operate with a high degree of autonomy
Preferred
Computer science or electrical engineering degrees are preferred
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