System Integration Architect

The Systems Engineer will lead system integration activities for complex, regulated medical devices across new product development and sustaining programs. This role is responsible for integrating hardware, embedded software, mobile applications, wireless technologies, and cloud-connected services while ensuring compliance with quality and regulatory requirements.

Bachelor's degree in Systems Engineering, Biomedical Engineering, Electrical Engineering, Software Engineering, Computer Science, or a related field with 5+ years of experience, or a Master's degree with 4+ years of experience.

Experience leading integration of complex hardware and software systems.

Strong understanding of systems engineering, architecture, interface management, and requirements allocation.

Experience in regulated industries such as medical devices, aerospace, automotive, or similar.

Hands-on collaboration with hardware, firmware, software, and systems teams.

Knowledge of design controls, configuration management, change management, and defect tracking.

Strong analytical, troubleshooting, and communication skills.

Ability to work independently and succeed in a cross-functional environment.

Experience supporting Class II or Class III medical device development and regulatory submissions.

Experience with connected or software-enabled medical devices.

Familiarity with IEC 62304, IEC 60601, ISO 14971, or related standards.

Experience integrating mobile applications, Bluetooth, Wi-Fi, and cloud-based solutions.

Experience with DOORS, Jama, JIRA, Polarion, or similar tools.

Experience supporting verification, validation, design transfer, and automated system-level testing.

Strong organizational skills, attention to detail, and systems-thinking mindset.