Lead Systems Engineer — Cross-Discipline, Reg-Ready

DIRECT SALES, US; Newark (DE); On-site; USD 98,000 - 153,000; Full time

Benefits offered by this job

Annual bonus

Training & development

Job summary

Hologic, Inc. is seeking a Lead Systems Engineer to own system-level definition, integration, and verification of capital hardware equipment. You will lead cross-disciplinary teams and ensure requirements are well-defined, traceable, and compliant throughout the product lifecycle.

This role emphasizes risk management, regulatory readiness, and collaboration with quality, manufacturing, and software teams. You will mentor junior engineers and drive continuous improvement of processes, tools, and

Qualifications

• Bachelor’s degree in Systems Engineering, Electrical, Mechanical, Software or related field.
• 7+ years of experience in systems engineering or equivalent multi-disciplinary role.
• Proven experience leading complex cross-functional projects or products.
• Hands-on experience with requirements management, system architecture, and system integration/verification.

Responsibilities

• Lead the definition of system requirements, use cases, and interfaces based on customer, business, and regulatory needs.
• Develop and maintain system architecture, subsystem breakdown, and control documents.
• Ensure proper requirements flow-down and traceability from system to subsystems and components.
• Serve as the primary technical point of contact for system-level topics across cross-functional teams.
• Provide technical support and guidance to cross-functional teams to ensure alignment with system architecture and requirements.
• Lead technical reviews (requirements, design, integration, verification) and drive closure of actions and risks.
• Plan and lead system integration activities, including test strategy, test plans, and test execution at system level.
• Coordinate and perform system verification and validation to ensure compliance requirements and fitness for use.
• Analyze test results, lead troubleshooting, and drive root cause investigations and corrective actions.
• Support product sustainability, including change impact assessments.
• Identify, track, and mitigate technical risks; support FMEA and other risk management activities.
• Collaborate with cross-functional team to ensure design compliance, reliability, and sustainability.
• Collaborate with product management and marketing to translate customer needs into system capabilities.
• Contribute to project planning, effort estimation, milestones, and system-level deliverables.
• Support regulatory submissions, audits, and customer interactions as the system technical owner.
• Mentor junior systems and design engineers; promote best practices in systems engineering.
• Champion continuous improvement of requirements management, architecture, and verification processes and tools.

Skills

Systems engineering

Requirements management

Cross-functional leadership

Test & verification

Regulatory compliance

Root cause analysis

Risk management

MBSE

Education

Bachelor’s degree in Systems Engineering

Master’s degree

Tools

DOORS

Jama

Polarion

Job description

Hologic, Inc. is seeking a Lead Systems Engineer to own system-level definition, integration, and verification of capital hardware equipment. You will lead cross-disciplinary teams and ensure requirements are well-defined, traceable, and compliant throughout the product lifecycle.

This role emphasizes risk management, regulatory readiness, and collaboration with quality, manufacturing, and software teams. You will mentor junior engineers and drive continuous improvement of processes, tools, and