Lead Systems Engineer – Medical Devices

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

Benefits offered by this job

Annual bonus

Competitive salary

Training & development

Job summary

Hologic, Inc. is seeking a Lead Systems Engineer to provide technical leadership across hardware, software, mechanical, electrical, clinical, manufacturing and regulatory functions.

You will own the overall system architecture, drive requirement development and verification strategies, and lead cross-functional teams to deliver compliant, patient-safe medical devices. You will influence technical strategy, manage risk, and coordinate design transfer while maintaining performance, cost, and

Qualifications

• Regulated medical devices experience required.
• 8+ years lifecycle development in complex systems.
• Expertise in requirements management and traceability.
• Able to lead cross-functional teams and influence technical decisions.

Responsibilities

• Own the system architecture and align requirements with verification strategies.
• Lead system decomposition across software, hardware, and clinical workflows.
• Define system-level performance metrics and acceptance criteria.
• Lead system integration and resolve cross-functional issues affecting safety, quality or usability.
• Drive trade-off analyses balancing performance, risk, usability, manufacturability, reliability, and cost.
• Mentor engineers and lead technical reviews across programs.
• Support regulatory submissions with documentation and design evidence.
• Transfer design to manufacturing and ensure design control deliverables are complete.

Skills

Systems engineering

Requirements management

Systems modeling

System integration

Root cause analysis

Regulatory knowledge

Electrical safety standards

Software lifecycle

PLM systems

Education

Master’s Degree

College degree

Tools

Oracle

Job description

Hologic, Inc. is seeking a Lead Systems Engineer to provide technical leadership across hardware, software, mechanical, electrical, clinical, manufacturing and regulatory functions.

You will own the overall system architecture, drive requirement development and verification strategies, and lead cross-functional teams to deliver compliant, patient-safe medical devices. You will influence technical strategy, manage risk, and coordinate design transfer while maintaining performance, cost, and