Systems Software Engineer

Elumn8 Medical, Inc. • Campbell, CA

5h

About The Position

The Systems Software Engineer is expected to develop, document, maintain and optimize medical graphical display software in C/C++ for Windows and Linux environments as part of the R&D team. They are additionally expected to lead or perform software testing activities relating to compliance with IEC 60601, IEC 62304 and ISO 14971. This position requires the team member to learn and understand medical device safety standards, risk management, human factors engineering (UI/UX design), and pre-/post-clinical study development.

Requirements

• Bachelor's degree in Computer Science or Computer Engineering or relevant fields such as Biomedical Engineering/Bioengineering.
• Minimum three (3) years' experience in MEDTECH with prior experience in product commercialization.
• 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 in IEC 60601, IEC 62304 and ISO 14971.
• Prior experience with Class 2 or above medical device is a must; prior experience in cardiovascular intervention is preferred.
• Ability to troubleshoot and debug software systems with sparse documentation.
• Ability to communicate technical issues and describe software to a general audience, such as for 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 development of embedded systems (bare-metal C/C++) is preferred and recommended.
• Proficiency with development for Linux 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.

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 as required for FDA submissions such as 510k submission.
• Perform other work-related tasks as assigned.

What This Job Offers

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