Medical Device Software Test Engineer

Important Note: for this position, we're currently considering candidate available to work in a hybrid model (4 days/week) in the following locations:
Newton (Massachusetts), and Mounds View (Minnesota).

We are seeking a Software Test Engineer (Manual Testing with Automation Exposure) to join an innovative R&D team developing advanced medical device technologies for cardiac electrophysiology and visualization systems. This role focuses on ensuring the quality, reliability, and safety of real-time software used in critical clinical environments.

You will work on a cutting-edge platform that combines real-time visualization, high-performance data processing, embedded systems, and hardware-software integration to support the diagnosis and treatment of complex heart rhythm disorders.

• Bachelor’s or Master’s degree in Software Engineering, Computer Science, Computer Engineering, Electrical Engineering, or a related technical field.
• Experience in software testing, verification, or quality engineering.
• Understanding of medical device software verification and regulated development environments.
• Familiarity with IEC 62304, FDA software guidance, and software verification methodologies.
• Experience developing and executing manual test plans, test cases, and verification protocols.
• Experience with test management and requirements tools such as Polarion, JAMA, Test Rail, Azure Dev Ops/TFS, or similar.
• Strong analytical, troubleshooting, and documentation skills.
• Ability to collaborate effectively within cross-functional engineering teams.

• Experience with medical devices or healthcare software systems.
• Experience testing real-time or high-performance visualization applications.
• Knowledge of Python, C++, C#, or similar languages.
• Experience with test automation, regression testing, and system-level testing.
• Familiarity with hardware debugging tools such as oscilloscopes and function generators.
• Experience with Git or other version control systems.
• Knowledge of FDA-regulated software quality processes and technical documentation practices.

• Test the functionality, reliability, and performance of complex medical device software systems.
• Design, develop, and execute manual test plans, protocols, and test cases.
• Support software verification activities for regulated healthcare products.
• Perform workflow analysis and identify areas for quality and usability improvements.
• Document test execution results and communicate findings clearly to engineering stakeholders.
• Collaborate with software, systems, QA, and hardware engineering teams to investigate and resolve software defects.
• Support maintenance of test environments, hardware configurations, and software builds.
• Participate in improving verification methodologies, testing processes, and automation capabilities.
• Contribute to ensuring compliance with FDA and IEC 62304 quality standards.
• Help drive continuous improvements in product quality, reliability, and engineering efficiency.