Role : Sr Software Engineer(Embedded Engineer)
Location : 6501 Six Forks Road, Raleigh, NC 27615 (Onsite)
Experience with IEC 62304 and software development on an FDA-regulated device. Good exposure to Atlassian Jira.
Architecting Host Software (C++), WPF, .NET
Design and development of embedded software for the legacy and new generation of the medical device (C and C++).
Responsible for design and development of software tools to support manufacturing the medical device (C, C# and C++)
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.
Proficiency 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 is required.
Proficient with Windows 10.
Proficient with cryptographic algorithm
Perform other duties as assigned based on business needs.
7 years of software development is required
Software development for medical device experience is required.
Bachelor of Science in Computer Science or equivalent is required.
The job requires on-site presence.
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