Santa Clara, CA

The Staff R&D Software Engineer will be focused on Software Engineering and will use design and technical skills in the development of embedded software for innovative electronic products to treat peripheral and heart valve diseases. The Sr. Staff R&D Software Engineer will participate on multiple cross-functional development teams that manage projects from concept through commercialization and will perform and support a variety of development and engineering activities focused on embedded software design and development.

Essential Job Functions

• Design and develop software for medical device product(s) in full compliance with the company’s Design Control requirements and consistent with FDA, ISO, and MDR requirements.
• Participate in Software related activities in cross-functional development team that manage projects from concept through commercialization.
• Responsible for knowing and planning activities consistent with the company’s quality policy and quality objectives.
• Responsible for ensuring lab notebooks are documented in a timely manner and consistent with the applicable SOP.
• Design and development of RTOS embedded software for use in medical devices.
• Develop new and novel products based on user defined needs.
• Understanding of hardware communications drivers such as 1-Wire, I2C, SPI, UART, USB, CAN communication protocols.
• Development of technical specifications and requirements from Product Level requirements.
• Integrate, test, and debug embedded firmware designs on hardware platform.
• Development, execution and functional verification to medical device standards.
• Initiate and conduct Software design reviews.
• Support of medical device standards, and transfer to production.
• Develop, execute, and document system test plans and test reports to medical device standards.
• Collaborate with Systems Engineers to ensure all design inputs and product requirements are addressed.
• Participate in dFMEA, Hazards Analysis, and Risk Analysis, etc.
• Audit processes and suggest and implement process improvements.
• Work with other Software and Electrical engineers in the development of design concepts.
• Provide mentoring to other engineers.
• Assist in Failure Investigations and Product RMA evaluations for software related issues.
• Other duties as assigned.

Requirements

• Bachelor’s Degree in Computer Science or Electrical Engineering with 8+ years’ experience in engineering preferably in the medical device industry or a master’s degree in Computer Science or Electrical Engineering with 5+ years in engineering preferably in the medical device industry.
• Demonstrated Proficiency in C language programming, C++ is a plus/desirable.
• Demonstrated Proficiency of development of Applications in Windows Environment using C# or other object-oriented programming language.
• Experience with MIPS/ARM/RISC-V based embedded microcontrollers, Medical Grade Single Board Computers experience is a plus.
• Hands on experience with development of BLE and WiFi implemented in embedded devices.
• Proficient in the use of software development tools including compilers, assemblers, emulators, and in-circuit debugging tools, Oscilloscopes and Logic Analyzers.
• Experience developing firmware for embedded systems in Bare Metal, RTOS and Linux environment.
• Proficient in the use of issue tracking tools such as JIRA and source control repository systems such as GIT.
• Experience with Configuration Management, Software V&V and SDLC processes.
• Effective communication skills with all levels of management.
• Ability to understand company business needs and develop products with features, costs, and performance suitable to those needs.
• Experience in all product design phases from concept to production.
• Experience with scripting language for developing automated software test scripts.
• Operate independently and adaptability to changing requirements with the ability to work in a fast-paced environment, managing multiple priorities.
• Experience with lasers and pulse discharge control systems is a plus.
• Employees may be required to lift objects up to 25lbs.