Systems Software Engineer
On-siteCampbell, California, United States
Campbell, California, United StatesOn-siteFull TimeBachelors Degree
Full TimeBachelors Degree
Job Summary
Develop, test, and document graphical user software for real-time greyscale images and interfaces as part of usability studies. Optimize and maintain existing systems, including porting code from Windows to Linux environments. Perform software risk analyses and adhere to medical industry standards such as IEC 60601, IEC 62304, and ISO 14971. Contribute to documentation for FDA submissions like 510k. Learn medical device safety standards, risk management, and human factors engineering. Troubleshoot software systems with sparse documentation and communicate technical issues to general audiences.
Required Qualifications
- 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
- 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
- Must occasionally lift and/or move up to 25 pounds
Desired Qualifications
- Proficiency in Python
- Proficiency in development of embedded systems (bare-metal C/C++)
- Proficiency with development for Linux
- Proficiency in UI/UX design
- Prior experience with AI/ML libraries, such as TensorFlow
- Prior experience in cardiovascular intervention
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