Systems Software Engineer

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.

Essential Duties and Responsibilities

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.

Minimum Qualifications (Knowledge, Skills, and Abilities)

• 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.

Physical Demands and Work Environment

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the functions. While performing the duties of this position, the employee is regularly required to talk or hear. The employee frequently is required to use hands or fingers, handle or feel objects, tools, or controls. The employee is occasionally required to stand; walk; sit; and reach with hands and arms. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this position include close vision, distance vision, and the ability to adjust focus. The noise level in the work environment is usually low to moderate.

Note

This job description in no way states or implies that these are the only duties to be performed by the employee(s) incumbent in this position. Employees will be required to follow any other job-related instructions and to perform any other job-related duties requested by any person authorized to give instructions or assignments. All duties and responsibilities are essential functions and requirements and are subject to possible modification to reasonably accommodate individuals with disabilities. To perform this job successfully, the incumbents will possess the skills, aptitudes, and abilities to perform each duty proficiently. Some requirements may exclude individuals who pose a direct threat or significant risk to the health or safety of themselves or others. The requirements listed in this document are the minimum levels of knowledge, skills, or abilities. This document does not create an employment contract, implied or otherwise, other than an “at will” relationship.