Lead Medical Systems Engineer

Hologic, Inc.; Newark (DE); On-site; USD 119,000 - 187,000; Full time

Job summary

Hologic, Inc. is seeking a Lead Systems Engineer in Newark, DE. This role provides engineering leadership across hardware, software, mechanical, electrical, clinical, manufacturing, quality, and regulatory functions to ensure safe and compliant medical devices.

You will drive requirement development, system architecture, risk management, integration, verification and validation, and design transfer while balancing cost, schedule, and performance. This is a senior leadership role with broad scope.

Qualifications

• Experience with complex medical systems in regulated environments.
• Ability to lead cross-functional engineering teams.
• Strong knowledge of FDA QSR and ISO 13485 standards.
• Experience with system verification and validation activities.
• Ability to translate user needs into engineering requirements.

Responsibilities

• Own the overall system architecture and ensure alignment with requirements.
• Lead system decomposition across software, hardware, electrical and mechanical domains.
• Define system performance metrics and acceptance criteria.
• Drive integration activities and resolve cross-functional issues.
• Lead risk management activities including FMEA development and risk control.
• Support regulatory submissions with technical documentation and evidence.
• Mentor engineers and lead technical reviews.
• Develop and improve system engineering processes and tools.

Skills

Systems engineering

Requirements management

Traceability

Systems modeling

Risk management

Regulatory knowledge

Education

Master’s Degree

PhD

Tools

Oracle

Job description

Hologic, Inc. is seeking a Lead Systems Engineer in Newark, DE. This role provides engineering leadership across hardware, software, mechanical, electrical, clinical, manufacturing, quality, and regulatory functions to ensure safe and compliant medical devices.

You will drive requirement development, system architecture, risk management, integration, verification and validation, and design transfer while balancing cost, schedule, and performance. This is a senior leadership role with broad scope.