Sr Engineer, Software Test

We are seeking a highly skilled Senior Engineer, Software Test to lead the design, development, and execution of test strategies for medical device systems. This role combines hands-on system-level testing with ownership of scalable automation frameworks to ensure product quality, reliability, and regulatory compliance.

The ideal candidate will drive both verification & validation activities and test automation infrastructure, working cross-functionally with software, hardware, systems, and quality teams to deliver high-quality medical devices.

• Design and develop comprehensive test strategies, plans, and test cases for medical device systems 

• Execute and oversee functional, integration, system-level, and performance testing  

• Lead verification and validation (V&V) activities in compliance with regulatory standards 

• Perform root cause analysis on defects and drive resolution with cross-functional teams 

• Review requirements and system architecture to ensure testability and coverage 

• Develop test reports, traceability matrices, and validation documentation 

• Design, develop, and maintain scalable automated test frameworks and infrastructure 

• Build automated test scripts using languages such as Python, C/C++, or similar 

• Integrate automated testing into CI/CD pipelines to enable continuous validation 

• Improve test efficiency, coverage, and reliability through automation and tooling 

• Evaluate and implement new tools and technologies to enhance test capabilities 

• Partner with software, hardware, systems, and quality teams to define test strategies and quality goals 

• Support system integration, product bring-up, and troubleshooting efforts 

• Collaborate with manufacturing and field teams on failure analysis and issue resolution 

• Mentor junior engineers and provide technical leadership in test methodologies 

• Bachelor’s or Master’s degree in Computer Engineering, Computer Science, Biomedical Engineering, or related field 

• 5+ years of experience in medical device testing, system validation, or software quality engineering 

• Strong understanding of system-level testing across hardware, software, and integrated systems 

• Experience with test automation frameworks and scripting (Python, C/C++, or similar) 

• Solid knowledge of verification & validation processes and defect tracking systems 

• Hands-on experience with lab equipment and system-level debugging 

• Strong analytical and problem-solving skills 

•  Medical Device industry experience.   

• Background in Agile/Scrum development environments.

• Experience with CI/CD systems and automated test pipelines 

• Experience with Linux/Unix environments 

• Background in both hardware and software system testing 

• Experience mentoring or leading engineering efforts

ONSITE position Monday - Friday in Irvine, CA. This position primarily works in an office environment. It requires frequent sitting, standing and walking. Daily use of a computer and other computing and digital devices is required. May stand for extended periods when facilitating meetings or walking in the facilities. 

The physical demands of the position described herein are essential functions of the job and employees must be able to successfully perform these tasks for extended periods. Reasonable accommodation may be made for those individuals with real or perceived disabilities to perform the essential functions of the job described.