Software Development Engineer

The Staff Software Development Engineer is a senior technical contributor responsible for the architecture, design, development, verification, and maintenance of software used in implantable spinal cord stimulation systems and supporting clinical applications. This role provides technical leadership across software development efforts while ensuring compliance with medical device regulations and quality standards. The Staff Engineer collaborates closely with cross-functional teams including Systems Engineering, Electrical Engineering, Firmware, Quality Assurance, Regulatory Affairs, Clinical Affairs, and Product Management to develop safe, reliable, and effective software solutions that improve patient outcomes.

• Lead the design and development of software for medical devices, clinician programmer applications, patient applications, and supporting cloud or desktop systems.
• Define software architecture and technical direction for complex projects spanning multiple software components.
• Develop high-quality, maintainable, and well-tested software following established software engineering principles and coding standards.
• Participate in product planning, requirements analysis, system design, risk analysis, implementation, verification, and product release activities.
• Ensure software development complies with applicable quality system regulations and standards, including FDA Quality System Regulation and other applicable standards.
• Perform technical reviews of software requirements, architecture, source code, test plans, and design documentation.
• Mentor software engineers by promoting engineering best practices, code quality, design patterns, and continuous improvement.
• Collaborate with systems, firmware, hardware, and clinical engineering teams to integrate software with implantable neurostimulation devices.
• Support cybersecurity, software reliability, and performance initiatives throughout the product lifecycle.
• Investigate field issues and implement corrective and preventive actions when required.
• Contribute to software process improvements, development tools, automated testing, and continuous integration pipelines.
• Participate in design reviews, hazard analyses, and risk management activities to ensure patient safety.
• Provide technical guidance during regulatory submissions and product audits.

• Bachelor's degree in Computer Science, Software Engineering, Computer Engineering, or related technical field.
• 6+ years of professional software development experience.
• Extensive experience designing and developing complex software applications using modern programming languages such as C#, C++, Kotlin.
• Experience developing software using object-oriented design principles and software architecture patterns.
• Strong understanding of Agile software development methodologies.
• Experience with version control systems such as Git.
• Strong analytical, debugging, and problem-solving skills.
• Excellent written and verbal communication skills.
• Demonstrated ability to lead technical initiatives without direct managerial responsibility.

• Master's degree in Computer Science, Engineering, or related field.
• Knowledge of No
  
  SQL
• Experience developing software for regulated medical devices.
• Knowledge of IEC standards, and FDA software guidance, and cybersecurity requirements for medical devices.
• Experience with Bluetooth Low Energy (BLE), embedded communications, or implantable medical device interfaces.
• Experience with automated testing frameworks, CI/CD pipelines, and static code analysis tools.
• Familiarity with cloud-connected medical systems and secure data communication.

• Deliver high-quality software that meets functional, performance, safety, and regulatory requirements.
• Drive technical decisions that improve scalability, maintainability, and reliability.
• Ensure software documentation is complete, accurate, and audit-ready.
• Reduce software defects through design reviews, code reviews, and comprehensive testing.
• Foster engineering excellence by mentoring developers and promoting software best practices.
• Support successful regulatory submissions and product releases through technical expertise and documentation quality.

Must be able to travel internationally and domestically, less than 15% of the time.

If onsite, this role is based in a temperature controlled professional office setting, which may include an office or cubicle with quiet to…