Manual Medical Device Test Engineer

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.

You will become part of a team developing advanced cardiac mapping and ablation technologies used to diagnose and treat complex heart rhythm disorders.

The platform combines:

• real-time visualization software
• embedded and connected systems
• advanced hardware-software integration
• medical-grade quality and safety standards

The engineering team operates in a fast-paced R&D environment focused on innovation, system reliability, and product quality. This role provides strong exposure to modern medical device software verification practices, cross‑functional collaboration, and highly impactful healthcare technologies.

• 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.

• Work on next‑generation medical technology transforming cardiac care and electrophysiology treatment.
• Contribute to products that directly improve and save patients’ lives.
• Gain experience with complex real‑time systems, advanced visualization software, and regulated healthcare products.
• Collaborate closely with multidisciplinary engineering and clinical teams.
• Join an innovative Med Tech environment with strong opportunities for professional growth and long-term impact.