Job Summary:
We are seeking a senior-level Systems Integration Architect to lead and execute system-level integration activities for complex, regulated medical devices. The role focuses on integrating hardware, embedded software, mobile applications, wireless technologies, and cloud-connected services across sustaining and new product development programs. The ideal candidate will have strong systems engineering and architecture expertise, the ability to independently lead integration efforts, and experience working across cross-functional engineering teams in regulated product development environments.
Key Responsibilities:
• Lead system integration planning and execution across the full product lifecycle, from early architecture through verification, design transfer, and sustaining activities.
• Define and manage system integration strategies, including integration sequencing, interface definition, and mitigation of integration risks.
• Support and maintain system architecture, interface definitions, and integration requirements across hardware and software domains.
• Coordinate end-to-end integration activities across embedded firmware, mechanical components, mobile applications, and cloud-connected services.
• Partner with Systems, Software, and Hardware Engineering teams to ensure requirements are clear, allocatable, and integrable.
• Identify integration issues early and drive resolution through root-cause analysis.
• Support system-level verification and validation by ensuring integrated systems are test-ready, traceable, and issues are resolved prior to formal testing.
• Communicate integration risks, technical tradeoffs, and system impacts.
• Lead technical reviews and provide technical guidance and mentorship.
• Ensure compliance with applicable quality system requirements.
• Communicate effectively with cross-functional teams and senior management regarding progress, risks, and issues.
Required Qualifications:
• Bachelor's degree in Systems Engineering, Biomedical Engineering, Electrical Engineering, Software Engineering, Computer Science, or a related technical field with 5-6 years of relevant experience, or a Master's degree in a related technical field with a minimum of 4 years of relevant experience.
• Demonstrated experience leading system integration for complex products involving both hardware and software.
• Strong understanding of system architecture, interface control, and multi-component system behavior.
• Experience working in regulated product development environments, including medical devices, aerospace, automotive, or similar industries.
• Hands-on experience collaborating across hardware, software, and systems disciplines.
• Working knowledge of design control, configuration management, defect tracking, and change management processes.
• Excellent written and verbal communication skills with the ability to communicate complex technical concepts to cross-functional stakeholders.
• Proven ability to work independently, prioritize effectively, and drive results in a matrixed organization.
• Experience supporting regulatory submissions for Class II/III medical devices.
Preferred Qualifications:
• Medical device experience, particularly with connected or software-enabled medical devices.
• Familiarity with IEC 62304, IEC 60601, ISO 14971, or similar standards.
• Experience integrating systems involving mobile applications, wireless technologies such as Bluetooth and Wi-Fi, and cloud-based services.
• Experience with requirements, configuration, and defect management tools such as DOORS and JIRA.
• Experience supporting system integration through verification, validation, and design transfer.
• Strong systems-thinking mindset with the ability to balance technical depth and broader system impacts.
• Strong organizational skills, ability to prioritize work, and consistent attention to detail.
• Experience developing or supporting automated system-level tests involving integrated mechanical, electrical, and software components.
