Systems Software Engineer

The essential functions include, but are not limited to the following:

• 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.

We are seeking a Systems Software Engineer for a full-time, on-site position based in Campbell, CA. In this role, you will design, develop, debug, document, maintain and optimize medical graphical display software in C/C++ for Windows and Linux environments. Additionally, you will 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. You will collaborate with cross-functional teams and ensure seamless performance across the organization. Your expertise will help drive innovation in the field of interventional cardiology., * 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 Python is preferred and recommended.
• Proficiency in development for Windows, specifically MSVC and CMake.
• Proficiency in development of embedded systems (bare-metal C/C++) is preferred and recommended.
• Proficiency with development for Linux is preferred and recommended.
• Proficiency with source code management tools, specifically Git.
• Prior experience with unit and integration testing.
• Proficiency in UI/UX design is preferred and recommended.
• Prior experience with AI/ML libraries, such as TensorFlow, is preferred and recommended.
• 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.

Elumn8 Medical, formerly known as Simpson Interventions, is dedicated to addressing unmet clinical needs in interventional cardiology. The company pioneers advancements in visualization, intelligence, and automation, driving innovation to improve patient outcomes. With a strong focus on technology and cutting-edge solutions, Elumn8 Medical is committed to transforming the future of cardiovascular care. By joining our team, you will contribute to developing groundbreaking technologies that redefine the standard of care in the industry.