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

We are seeking a Systems Integration Engineer to join a cross-functional engineering team responsible for bringing a complex medical device system from development through commercialization. This role is central to ensuring that hardware, software, and mechanical subsystems function together reliably, meet system-level requirements, and satisfy applicable regulatory and quality standards.

Key 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 across the organization 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.

Required Qualifications

• Bachelor's degree in Systems Engineering, Biomedical Engineering, Electrical Engineering, Mechanical Engineering, or a related field.
• 3+ years of experience in systems integration or systems engineering, ideally within a regulated medical device environment.
• Working knowledge of medical device design controls and applicable quality/regulatory standards.
• Experience integrating and testing complex multi-disciplinary systems (hardware, software, and/or mechanical).
• Strong understanding of requirements management, traceability, and system-level verification and validation methodologies.
• Excellent problem-solving skills and the ability to communicate effectively across engineering disciplines.

Preferred Qualifications

• Master's degree in a relevant engineering discipline.
• Experience with requirements management tooling.
• Familiarity with Agile or hybrid development environments within a regulated industry.
• Experience supporting regulatory submissions or interacting with regulatory bodies.
• Relevant professional certification (e.g., systems engineering or quality engineering credential).