Senior Software Engineer, Fresenius USA Manufacturing, Inc., a FMCNA company, Concord, California
Purpose and Scope:
Work on the design, development, modification testing and implementation of embedded software applications and systems operating within our suite of blood measurement instruments and electro-mechanical medical devices used in the kidney dialysis process. This will involve analyzing software requirements, following the appropriate software development process to properly embed the software, and ensuring that the software leads to the safe and effective operation of our medical devices.
Principal Duties and Responsibilities:
- Designing and developing embedded software that meets user and business requirements.
- Working on the development of embedded software using C, C++, C# and other programming languages to apply technical principles, theories, mathematical models and concepts specific to software engineering for analog, digital and mixed signal circuits along with other electrical devices.
- Developing and establishing detailed systems software design input specifications to ensure proper software functionality and cost-effective design.
- Authoring testing plans and software engineering test reports using proper embedded software and electrical engineering documentation practices.
- Participating in software Verification and Validation activities during Design Transfer from design stage to medical device manufacturing.
- Designing real-time code structures interrupt servicing modules and operating kernels.
- Implementing software that controls light emission, detection with various optical devices.
- Writing database and analysis software that interfaces with electro-medical blood measurement lab equipment.
- Verifying and validating code functions for blood analysis techniques.
Education Experience and Required Skills:
Position requires a Bachelor’s degree (or an equivalent foreign degree) in Computer Science, Electrical or Electronics Engineering or a closely related field and 3 years of experience designing and developing embedded software systems. Must also have worked on the full software development life cycle for systems used in FDA regulated technology (21 CFR Part 11 or 21 CFR Part 820) as well as with programming at the machine/processor level using C, C++ and real time operating system and have 3 years of experience (which can have been gained concurrently with the primary experience requirement above) with the following:
- Interfacing digital and analog circuits with programmable controllers.
- Controller devices/systems where timing of sampling, enabling, disabling and data management is critical.
- Programming GUI (Graphical User Interface) on Windows platform for production/assembly floor.
- Performing system design and architecture.
EO/AA Employer: Minorities/Females/Veterans/Disability/Sexual Orientation/Gender Identity
Fresenius Medical Care North America maintains a drug-free workplace in accordance with applicable federal and state laws.
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