Principal, Software Engineer

About the Role The Principal Software Engineer is responsible for maintaining, enhancing, and supporting software for on-market medical device products, ensuring continued product reliability, compliance, cybersecurity, and lifecycle sustainability.

This role focuses on evaluating and implementing software changes driven by end-of-life (EOL) components, supplier hardware updates, cybersecurity requirements, and field-reported issues.

The position investigates software anomalies, assesses impacts to existing systems, and defines practical, compliant solutions that maintain product performance and customer satisfaction.

The role serves as a key liaison between engineering, customer-facing teams, product security, verification and validation, and global software development organizations. It ensures that software changes are properly assessed, documented, tested, and released in accordance with quality system requirements and medical device regulations.

The Principal Software Engineer collaborates closely with onshore and offshore development and V&V teams throughout the software development lifecycle, providing technical inputs for testing, validating software modifications, supporting troubleshooting activities, and maintaining software configuration management.

The role enables successful delivery of software updates while ensuring adherence to company policies, regulatory requirements, and product quality standards.

This is an onsite position located at our main campus in Lake Forest, California. What You'll Do

• Primary function is to code and/or software updates for on-market medical device systems.
• Collaborate closely with the software development teams, Technical Support, Field Service, Manufacturing, Clinical and other operation organizations to support necessary software changes initiated by reported anomalies, changes in use cases, material or hardware changes that impact software, cybersecurity, regulatory updates, and other.
• Troubleshoot, and define solutions to meet expectations, and incorporate changes according to defined processes and procedures, in line with industry standards and regulations.
• Maintain configuration management and change control according to the associated product Configuration. What We're Looking For
• Strong experience in software engineering for medical device products, with focus on sustaining on-market software and lifecycle management.
• Ability to investigate software anomalies, assess impacts, and define compliant solutions.
• Experience collaborating across cross-functional teams including engineering, customer-facing groups, and regulatory/quality teams.
• Familiarity with quality systems requirements and medical device regulations, cybersecurity concepts, and V&V processes.
• Excellent problem-solving, communication, and documentation skills. Nice to Have
• Experience with end-of-life (EOL) components, supplier hardware updates, and field-reported issues.