Medical Device Systems Integration Engineer

Lumicity; Massachusetts; On-site; USD 110,000 - 150,000; Full time

Job summary

Lumicity seeks a Systems Integration Engineer to join a cross-functional engineering team advancing a complex medical device from development to commercialization. You will ensure that hardware, software, and mechanical subsystems function together, meeting system-level requirements.

You will collaborate across disciplines to verify design controls, manage requirements traceability, support design reviews, and assist with regulatory submissions as part of the product development lifecycle.

Qualifications

• Bachelor's degree in a related engineering field.
• 3+ years in systems integration or systems engineering.
• Working knowledge of medical device design controls and quality/regulatory standards.
• Experience integrating and testing complex multi-disciplinary systems (hardware, software, and/or mechanical).
• Strong understanding of requirements management and system-level verification/validation methodologies.
• Excellent problem-solving skills and cross-disciplinary communication.

Responsibilities

• Lead integration of hardware, software, and mechanical subsystems into a unified device-level system.
• Develop and maintain system-level requirements, architecture documentation, and interface control documentation.
• Partner with engineering disciplines to identify, troubleshoot, and resolve integration issues.
• Plan and execute system-level verification and validation testing, including protocol development, execution, and reporting.
• Support risk management activities related to system design and integration.
• Maintain requirements traceability across system and subsystem levels through verification and validation.
• Participate in design reviews and support design control processes throughout the product development lifecycle.
• Support root cause investigations and corrective actions for system-level issues identified during testing or field use.
• Contribute technical documentation supporting regulatory submissions.

Skills

Systems integration

Requirements mgmt

Cross-functional collaboration

Regulatory/quality standards

Verification and validation

Problem solving

Documentation

Education

Engineering degree

Job description

Lumicity seeks a Systems Integration Engineer to join a cross-functional engineering team advancing a complex medical device from development to commercialization. You will ensure that hardware, software, and mechanical subsystems function together, meeting system-level requirements.

You will collaborate across disciplines to verify design controls, manage requirements traceability, support design reviews, and assist with regulatory submissions as part of the product development lifecycle.