Manual Medical Device Test Engineer

Intellias; Newton (MA); On-site; USD 80,000 - 110,000; Full time

Job summary

Intellias is 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 perfect for those passionate about software quality and medical device verification.

Your responsibilities include testing medical device software systems, developing test plans, and collaborating with cross-functional teams. The ideal candidate has experience in regulated environments and a degree in a related field, with strong opportunities for professional growth.

Qualifications

• Hands-on experience testing complex software systems within regulated environments.
• Understanding of medical device software verification and regulated development environments.
• Experience developing and executing manual test plans and verification protocols.

Responsibilities

• Test the functionality, reliability, and performance of complex medical device software systems.
• Design, develop, and execute manual test plans, protocols, and test cases.
• Document test execution results and communicate findings clearly to engineering stakeholders.

Skills

Software testing

Verification

Collaboration

Analytical skills

Education

Bachelor’s or Master’s degree in Software Engineering or related field

Tools

Polarion

JAMA

TestRail

Azure DevOps/TFS

Job description

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.

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.

Why this position:

• 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 MedTech environment with strong opportunities for professional growth and long-term impact.