Sr. Embedded Software Engineer

The Sr Embedded Software Engineer located in our Milpitas, CA location oversees the design, development, and validation of software for embedded systems, ensuring compliance with FDA requirements. They play a crucial role in software design, coding, and validation, address moderate scope problems, and participate in software development activities under guidance and mentoring junior engineers. Adherence to FDA-compliant Design Control procedures and proficiency in software implementation are key aspects of the role.

• Design and implement software in current programming languages (e.g. C, C++, C#, python).
• Working from requirement specifications, develops, maintains, and updates detailed design and interface specifications.
• Participates in and supports the implementation, development, enhancements, and modifications to software source code, scripts, and procedures.
• Debugs, troubleshoots, and isolates software problems as well as offer strategic solutions, analysis, and advice regarding identified issues for future development.
• Assist in the evaluation of selected designs through testing and full documentation of the results.
• Work on problems of moderate scope where analysis of situations or data requires evaluation of identifiable factors.
• Exercise judgment within defined procedures and practices to determine appropriate action.
• Participate in software development, verification and validation following the guidance of software lead.
• Follow approved Design Control procedures for software development in accordance with FDA guidelines.
• Contributes to and supports writing, updating, developing and maintaining Hazard/Risk analysis specifications.
• Contributes to and supports root-cause analysis of failures.

• Bachelor’s degree in computer science, Engineering Mathematics, or related field with minimum 7 years of related experience or Master's Degree with 4+ years of related experience
• Excellent written and verbal communication skills
• Strong familiarity with current development tools (IDEs, debuggers, unit test frameworks)

• Experience with middleware frameworks, protocol stacks, or system-level software.  Examples: USB stack, BLE stack, TCP/IP, file systems, etc.
• Experience building end-to-end systems (firmware → middleware → application)

• Experience testing software is a plus
• Knowledge of design controls and regulations for medical device development is a plus
• Knowledge of the principles of quality software engineering as described by software lifecycle development processes that are consistent with ISO, IEEE, or other FDA recognized standards is a plus
• Experience with software development life cycle processes is a plus

In specific locations, the pay range may vary from the range posted.