Lead Medical Device Systems Engineer

DIRECT SALES, US; Newark (DE); On-site; USD 119,000 - 187,000; Full time

Job summary

Hologic leads the design and development of complex medical systems, driving architecture, risk management, and cross‑functional collaboration across hardware, software, and clinical workflows. The role focuses on ensuring regulatory compliance and lifecycle management from concept through commercialization.

The position requires deep systems engineering expertise, leadership, and a track record of delivering safe, effective medical devices within a regulated environment.

Qualifications

• Extensive systems engineering knowledge across hardware, software, mech, and clinical workflows.
• Experience with medical device regulatory requirements (FDA QSR, ISO 13485).
• Ability to lead cross‑functional teams and mentor engineers.

Responsibilities

• Own the overall system architecture and ensure alignment with requirements.
• Lead system decomposition and allocation across subsystems.
• Define performance metrics and acceptance criteria for product outcomes.
• Drive system integration and resolve cross‑functional issues affecting performance, safety, or usability.
• Lead risk management activities including FMEA and risk control.
• Coordinate design reviews, architecture reviews, and risk reviews.
• Develop and maintain system engineering processes, tools, and methods.

Skills

Systems engineering

Requirements management

System integration

Regulatory compliance

Leadership

Stakeholder management

Regulatory standards

Product lifecycle

Education

College degree

Master’s degree

Job description

Hologic leads the design and development of complex medical systems, driving architecture, risk management, and cross‑functional collaboration across hardware, software, and clinical workflows. The role focuses on ensuring regulatory compliance and lifecycle management from concept through commercialization.

The position requires deep systems engineering expertise, leadership, and a track record of delivering safe, effective medical devices within a regulated environment.