Software Engineer, Staff (Test)

Enchannel Medical • Irvine, CA

5d

About The Position

Enchannel Medical is 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 cardiac arrhythmia patients, our discerning technology, paired with our passion for innovation, leads to enduring outcomes. Position Overview The Software Engineer, Staff (Test) will execute verification and validation activities for our 3D cardiac mapping system, including designing and implementing test cases, driving investigations, and contributing to automation efforts. Your work will directly impact on the safety, performance, and reliability of our products through rigorous testing and cross-functional collaboration.

Requirements

• 5+ years of related hands-on experience as either a software test engineer, validation engineer, or in a similar role, with a preferred focus on software validation.
• Bachelor’s degree in scientific/engineering discipline or equivalent combination of education and experience. Computer science or electrical engineering degrees are preferred.
• Experience in testing complex, integrated systems involving software, hardware, and algorithms.
• Strong troubleshooting, analytical thinking, and debugging skills in multidisciplinary environments.
• Proficiency with test automation tools and scripting languages (e.g., Python, C++, etc).
• Experience independently authoring, executing, and maintaining test documentation, including protocols, reports, and traceability matrices.
• Working knowledge of test management tools such as Jira, TestRail, ADO, or similar platforms.
• Experience collaborating effectively in Agile development environments.
• Strong verbal and written communication skills for documentation and cross-functional collaboration.
• Ability to manage multiple testing activities, prioritize effectively, and take ownership of assigned work with minimal direction.

Nice To Haves

• Experience with cardiac, imaging, navigation, or other real-time clinical systems.
• Hands-on experience designing, developing and maintaining automated tests for complex systems.
• Proficiency with statistical analysis tools and MATLAB.
• Familiarity with IEC 62304 and software verification and validation processes for medical device software.
• Familiarity with medical device quality and safety standards, such as ISO 13485, IEC 60601, and FDA regulations (e.g., 21 CFR Part 820).

Responsibilities

• Execute verification and validation test plans in compliance with industry standards and regulatory requirements, including system-level, functional, performance, stress, and integration testing.
• Investigate software issues, characterize failure modes, document findings, and provide timely feedback to development teams.
• Collaborate with cross-functional teams to troubleshoot and resolve defects identified during testing.
• Create, modify, and maintain automated tests to support regression, reliability, and scalability goals.
• Author and maintain test documentation, including protocols, test matrices, and reports, to support notified body submission.
• Contributes to the maintenance and improvement of test setups, tools, and methodologies.
• Demonstrate ownership of assigned testing efforts and investigations with minimal direction.
• Maintain a high standard of quality and attention to detail in all work performed.

What This Job Offers

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