Provide technical and engineering work for R&D department as directed by the Sr. Manager, Software Engineering. This position will be responsible for software architectural design, advanced graphical user interface design and development on the host computer, cybersecurity design and implementation, designing and implementing tools to support manufacturing the medical system as well as software documentation for a complex system.

Responsibilities 

• Write software requirements for the host application and software tools
• Provide design input for GUI of system software
• Ensure FDA compliance of all software and potential Web-based applications
• Responsible for design, development and implementation of cybersecurity control methods meeting FDA NIST standards for host application software, firmware, and sub-systems
• Perform software testing against the requirements on the medical device and emulator
• Perform software unit testing
• Perform Static Analysis, Profiling, and Debugging on user facing software
• Responsible for making observations, taking measurement using laboratory equipment and tools, data processing, statistical analysis and carrying out test protocols
• Responsible for testing, system software debugging and troubleshooting the software (Visual Studio)
• Responsible for supporting software engineering product development from prototype through verification. Work with software test and quality teams in preparing test cases, plans and procedures.
• Responsible for driving innovation in software development.
• Interface with and assist with training and task completion through new and or more junior employees and vendors
• Approach to working technical issues that supports a schedule-oriented mindset and work ethic
• Design reviews, forms processing for software releases, documentation, other as assigned. This position requires the individual to be on-site.
• Perform other duties as assigned based on business needs.

Education

• Bachelor of Science in Computer Science, Physics, Math, Electrical Engineering required
• Master’s degree in related technical field preferred

Professional experience

• 7 years of software development
• Software development for medical device

Knowledge, skills, and abilities 

• Proficient with development tools used with C /C, and C#: Microsoft Visual Studio
• Ability to foster innovation in software development
• Proficient with Windows 10 Operating System
• Proficient with writing advanced C and C# code for complex system, managed code, Microsoft .NET framework environment, SQL database, Windows based GUI application development, such as MFC, MVVM, Experience in OpenGL, GPU/CUDA, OpenCV coding, API development for imaging processing, picture control or video playing, Boost, advanced C/C GUI programming skill in a human-safety-critical environment
• Proficient in implementing industry standard encryption methodologies (for data in transit and at rest), digital signature, and integrity check. (C/C , C#, PowerShell)
• Profiling/Optimizing software
• Cryptographic Algorithm
• Agile Software Development Methodology, Configuration Management Tools and Processes
• Experience with medical device. Medical devices standards like IEC62304, ISO14971, IEC60601
• Knowledge on B-Mode Ultrasound is plus
• Design experience with real-time systems, state machines and standard Windows applications
• Experience designing and running unit tests
• Experience integrating real-time systems and a Windows Host application
• Knowledge of FDA cybersecurity requirements, NIST, GDPR, EU ENISA