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Manual Medical Device Test Engineer
Accepting applicationsIntellias · Newton, MA
Full-Time Mid_senior Pythonaiaterfsic
Posted
1d ago
Category
Test
Experience
Mid_senior
Country
United States
We are seeking a detail-oriented Manual Medical Device Test Engineer to join an innovative healthcare technology program focused on next-generation cardiac mapping and ablation systems.
This role is ideal for an engineer passionate about software quality, medical device verification, and real-world patient impact. You will work closely with cross-functional engineering teams to validate complex medical device software used in electrophysiology procedures and contribute to technologies that help physicians improve and save patients' lives.
The ideal candidate brings hands-on experience testing complex software systems within regulated environments and enjoys solving challenging engineering problems in a collaborative, fast-paced setting.
The project focuses on the development of an advanced cardiac mapping and ablation platform designed to support the diagnosis and treatment of cardiac arrhythmias.
The system combines real-time software, high-performance visualization, hardware-software integration, and sophisticated clinical workflows to provide physicians with precise cardiac mapping and therapy delivery capabilities.
As part of the verification team, you will support testing activities across software features, workflows, and integrated system configurations to help ensure product quality, reliability, safety, and regulatory compliance.
Requirements:
Bachelor's or Master's degree in Software Engineering, Computer Science, Computer Engineering, Electrical Engineering, or a related technical field.
2+ years of experience in software verification, manual testing, or medical device testing.
Understanding of IEC 62304, FDA guidance, and regulated software development environments.
Experience developing and executing manual test plans, protocols, and test cases.
Strong understanding of software verification processes and documentation practices.
Experience working with test management tools such as Polarion, JAMA, TestRail, TFS, or similar platforms.
Ability to manage and maintain multiple hardware and software configurations.
Strong troubleshooting, analytical, and communication skills.
Will be a plus:
Experience testing medical devices or healthcare software systems.
Experience with real-time or high-performance visualization applications.
Exposure to Python-based test automation or scripting.
Experience with hardware debugging tools such as oscilloscopes or function generators.
Familiarity with Git or other version control systems.
Experience writing technical reports and verification documentation.
Responsibilities:
Test the functionality, reliability, and performance of medical device software systems.
Develop and execute manual test plans, test protocols, and verification procedures.
Perform workflow analysis and validate software behavior against functional and technical requirements.
Document test execution results, defects, and verification evidence in accordance with quality and regulatory standards.
Collaborate with software, systems, QA, and hardware engineering teams to investigate and resolve software defects.
Support configuration management across multiple hardware and software environments.
Contribute to product quality improvements and verification process enhancements.
Support verification activities within FDA-regulated and IEC 62304-compliant development environments.
Why this position:
Work on advanced medical technology used in real clinical procedures worldwide.
Contribute to products that directly improve patient outcomes and cardiac care.
Gain experience with cutting-edge electrophysiology systems, real-time software, and medical device verification.
Collaborate with multidisciplinary engineering teams in a highly innovative MedTech environment.
Be part of a fast-growing healthcare technology program with strong long-term impact and career growth opportunities.
Show more Show less
This role is ideal for an engineer passionate about software quality, medical device verification, and real-world patient impact. You will work closely with cross-functional engineering teams to validate complex medical device software used in electrophysiology procedures and contribute to technologies that help physicians improve and save patients' lives.
The ideal candidate brings hands-on experience testing complex software systems within regulated environments and enjoys solving challenging engineering problems in a collaborative, fast-paced setting.
The project focuses on the development of an advanced cardiac mapping and ablation platform designed to support the diagnosis and treatment of cardiac arrhythmias.
The system combines real-time software, high-performance visualization, hardware-software integration, and sophisticated clinical workflows to provide physicians with precise cardiac mapping and therapy delivery capabilities.
As part of the verification team, you will support testing activities across software features, workflows, and integrated system configurations to help ensure product quality, reliability, safety, and regulatory compliance.
Requirements:
Bachelor's or Master's degree in Software Engineering, Computer Science, Computer Engineering, Electrical Engineering, or a related technical field.
2+ years of experience in software verification, manual testing, or medical device testing.
Understanding of IEC 62304, FDA guidance, and regulated software development environments.
Experience developing and executing manual test plans, protocols, and test cases.
Strong understanding of software verification processes and documentation practices.
Experience working with test management tools such as Polarion, JAMA, TestRail, TFS, or similar platforms.
Ability to manage and maintain multiple hardware and software configurations.
Strong troubleshooting, analytical, and communication skills.
Will be a plus:
Experience testing medical devices or healthcare software systems.
Experience with real-time or high-performance visualization applications.
Exposure to Python-based test automation or scripting.
Experience with hardware debugging tools such as oscilloscopes or function generators.
Familiarity with Git or other version control systems.
Experience writing technical reports and verification documentation.
Responsibilities:
Test the functionality, reliability, and performance of medical device software systems.
Develop and execute manual test plans, test protocols, and verification procedures.
Perform workflow analysis and validate software behavior against functional and technical requirements.
Document test execution results, defects, and verification evidence in accordance with quality and regulatory standards.
Collaborate with software, systems, QA, and hardware engineering teams to investigate and resolve software defects.
Support configuration management across multiple hardware and software environments.
Contribute to product quality improvements and verification process enhancements.
Support verification activities within FDA-regulated and IEC 62304-compliant development environments.
Why this position:
Work on advanced medical technology used in real clinical procedures worldwide.
Contribute to products that directly improve patient outcomes and cardiac care.
Gain experience with cutting-edge electrophysiology systems, real-time software, and medical device verification.
Collaborate with multidisciplinary engineering teams in a highly innovative MedTech environment.
Be part of a fast-growing healthcare technology program with strong long-term impact and career growth opportunities.
Show more Show less