Sr. Embedded Software Engineer

The Sr Embedded Software Engineer 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.

• 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.