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Medical Device Software Test Engineer
Accepting applicationsIntellias · Minnesota, United States
Full-Time Mid_senior C++Pythonaiaterf
Posted
1d ago
Category
Test
Experience
Mid_senior
Country
United States
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.
Requirements:
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, TestRail, Azure DevOps/TFS, or similar.
Strong analytical, troubleshooting, and documentation skills.
Ability to collaborate effectively within cross-functional engineering teams.
Will be a plus:
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.
Responsibilities:
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.
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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.
Requirements:
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, TestRail, Azure DevOps/TFS, or similar.
Strong analytical, troubleshooting, and documentation skills.
Ability to collaborate effectively within cross-functional engineering teams.
Will be a plus:
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.
Responsibilities:
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.
Show more Show less