Software Engineer Principal Test

ENCHANNEL MEDICAL LTD; Irvine (CA); On-site; USD 120,000 - 160,000; Full time

Job summary

A medical technology company in California is seeking a Principal Software Engineer to design testing strategies for their innovative 3D cardiac mapping system. This role entails leading verification, validation activities, and collaboration across engineering teams. Candidates should have over 11 years of experience in software validation, a strong background in regulatory standards, and skills in test automation tools. The company fosters a diverse workforce and offers a competitive pay structure based on experience and qualifications.

Qualifications

• 11+ years of experience in software testing or validation.
• Experience with regulatory submissions like 510(k).
• Familiarity with IEC 62304 software processes.

Responsibilities

• Design and lead testing strategies for complex systems.
• Collaborate with cross-functional teams for root-cause analysis.
• Mentor team members and maintain high test design standards.

Skills

Software validation

Test automation tools

Analytical thinking

Troubleshooting skills

Collaboration in Agile environment

Python and C++ scripting

Education

Bachelor’s degree in a scientific/engineering discipline

Tools

Jira

TestRail

Job description

Overview

Position Title: Software Engineer, Principal

Department: R &D

Reports to: Sr. VP, R &D

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, Principal (Test) will design and implement testing strategies for our 3D cardiac mapping system while remaining hands-on with verification and validation activities. You will play a critical role in ensuring the safety, performance, and reliability of our products through rigorous system-level testing and cross-functional collaboration.

Responsibilities

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

• 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.

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.

• 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.

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 applicable law.

Only qualified candidates will be contacted.