Systems Software Engineer

Elumn8 Medical, Inc. • Campbell, CA

1h

About The Position

The Systems Software Engineer develops, documents, maintains, and optimizes medical graphical display software in C/C++ for Windows and Linux as part of the R&D team. The role also leads or performs software testing activities related to compliance with IEC 60601, IEC 62304, and ISO 14971. The engineer is expected to learn and apply medical-device safety standards, risk management, human factors engineering (UI/UX design), and pre- and post-clinical study development.

The position includes developing and documenting software for real-time grayscale image display, supporting usability studies, maintaining and porting software systems, performing software risk analyses, and contributing to regulatory documentation such as FDA 510(k) submissions. The employee may also be assigned other work-related tasks.

Requirements

• Bachelor's degree in Computer Science, Computer Engineering, or a relevant field such as Biomedical Engineering or Bioengineering.
• At least three years of experience in medtech, including prior product commercialization experience.
• Proficiency in C and C++.
• Proficiency in development for Windows, specifically MSVC and CMake.
• Proficiency with source code management tools, specifically Git.
• Prior experience with unit and integration testing.
• Working knowledge of IEC 60601, IEC 62304, and ISO 14971.
• Prior experience with a Class 2 or higher medical device.
• Ability to troubleshoot and debug software systems with sparse documentation.
• Ability to communicate technical issues and describe software to a general audience, such as in team-wide meetings or FDA documentation.
• Ability to work independently in a fast-paced environment.
• Ability to interact professionally at all organizational levels.

Nice To Haves

• Proficiency in Python is preferred and recommended.
• Proficiency in embedded systems development using bare-metal C/C++ is preferred and recommended.
• Proficiency in Linux development is preferred and recommended.
• Proficiency in UI/UX design is preferred and recommended.
• Prior experience with AI/ML libraries such as TensorFlow is preferred and recommended.
• Prior experience in cardiovascular intervention is preferred.

Responsibilities

• Develop, test, and document graphical user software for displaying real-time greyscale images.
• Develop, test, and document graphical user interfaces as part of usability studies and reports.
• Optimize and maintain existing software systems, including graphical user software and embedded systems.
• Port existing software systems from a Windows environment to a Linux environment.
• Perform and document software risk analyses.
• Adhere to medical industry standards such as IEC 60601, IEC 62304, and ISO 14971.
• Contribute to documentation work required for FDA submissions, such as a 510(k) submission.
• Perform other work-related tasks as assigned.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level