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Senior Medical Device Test Engineer

Vacancy details
Test Engineering
Manual Test Engineer
Senior
United States
Hybrid
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We are seeking a Senior Software Test Engineer to join an innovative healthcare technology program focused on next-generation cardiac mapping and ablation systems.

This role offers the opportunity to work on cutting-edge electrophysiology technology combining real-time software, advanced visualization, and integrated medical device platforms used in clinical environments worldwide. You will play a key role in ensuring the quality, reliability, and performance of highly complex medical systems that directly impact patient outcomes.

The ideal candidate brings strong experience testing complex software systems within regulated environments, enjoys solving integration challenges, and thrives in collaborative, fast-paced engineering organizations.

What project we have for you

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 high-performance visualization software, real-time data processing, hardware-software integration, and sophisticated clinical workflows to provide physicians with precise cardiac mapping and therapy delivery capabilities.

As part of the software verification and validation team, you will contribute to testing and quality activities across complex integrated systems, collaborating closely with software, systems, electrical, mechanical, and QA engineering teams.

What you will do

  • Test the functionality, reliability, and performance of complex medical device software systems.
  • Develop and execute manual test plans, verification protocols, and system-level test procedures.
  • Validate software functionality against technical, functional, and regulatory requirements.
  • Perform workflow analysis and identify opportunities for quality and usability improvements.
  • Investigate, document, and help resolve software defects and integration issues.
  • Collaborate with software, systems, QA, electrical, and mechanical engineering teams throughout the development lifecycle.
  • Support verification activities in compliance with FDA and IEC 62304 requirements.
  • Contribute to continuous improvements in testing methodologies, product quality, and verification processes.
  • Help maintain and support multiple hardware and software configurations across test environments.

What you need for this

Requirements:

  • Bachelor’s or Master’s degree in Computer Science, Computer Engineering, Electrical Engineering, Software Engineering, or a related technical field.
  • 5+ years of experience in software testing, software verification, or medical device testing.
  • Strong understanding of IEC 62304, FDA guidance, and regulated software development environments.
  • Experience developing and executing manual test plans, protocols, and system-level verification activities.
  • Experience testing complex real-time or high-performance software applications.
  • Strong troubleshooting and defect investigation skills within integrated hardware/software systems.
  • Experience with test management tools such as Polarion, JAMA, TestRail, TFS, or similar platforms.
  • Strong communication and cross-functional collaboration skills.

Will be a plus:

  • Experience with electrophysiology, medical imaging, or other advanced medical device systems.
  • Experience with Python-based test automation or scripting.
  • Experience debugging hardware using oscilloscopes, function generators, or similar tools.
  • Familiarity with Git or other version control systems.
  • Experience writing technical reports and verification documentation.
  • Experience working within multidisciplinary engineering environments involving systems, software, electrical, and mechanical teams.

What it’s like to work at Intellias

At Intellias, where technology takes center stage, people always come before processes. By creating a comfortable atmosphere in our team, we empower individuals to unlock their true potential and achieve extraordinary results. That’s why we offer a range of benefits that support your well-being and charge your professional growth.
We are committed to fostering equity, diversity, and inclusion as an equal opportunity employer. All applicants will be considered for employment without discrimination based on race, color, religion, age, gender, nationality, disability, sexual orientation, gender identity or expression, veteran status, or any other characteristic protected by applicable law.
We welcome and celebrate the uniqueness of every individual. Join Intellias for a career where your perspectives and contributions are vital to our shared success.

Skills

Healthcare
Manual_Test_Engineering
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