Lead Systems Engineer, Medical Devices

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

Job summary

Hologic, Inc. in Newark, Delaware, is seeking a Lead Systems Engineer to provide leadership across hardware, software, mechanical, electrical, and regulatory functions for safe, effective medical devices.

You will own system architecture, drive risk management and verification/validation efforts, and guide cross-functional teams toward compliant, high-quality product development and successful lifecycle management.

Qualifications

• Experience throughout the product lifecycle in development and sustaining of complex medical systems with mechanical, electrical and software components within a regulated environment.
• Experience with automated tools for requirements and traceability management.
• Experience with automated tools for defect and issue tracking.
• Strong knowledge of FDA QSR and ISO 13485 is preferred.

Responsibilities

• Own the overall system architecture and ensure alignment between product requirements, subsystem requirements, interfaces, and verification strategies.
• Lead system decomposition and allocation of requirements across software, hardware, electrical, mechanical, and clinical workflows.
• Define system-level performance metrics and acceptance criteria to ensure successful product outcomes.
• Lead system integration activities and resolve cross-functional technical issues affecting product performance, safety, quality, or usability.
• Drive engineering trade-off analyses balancing performance, risk, usability, manufacturability, reliability, and cost.

Skills

Systems engineering

Requirements management

System integration

Technical leadership

Regulatory knowledge

Risk management

Cross-functional collaboration

Design verification/validation

Education

College degree

Master’s degree

Tools

Oracle

Requirements management tools

Traceability tools

Job description

Hologic, Inc. in Newark, Delaware, is seeking a Lead Systems Engineer to provide leadership across hardware, software, mechanical, electrical, and regulatory functions for safe, effective medical devices.

You will own system architecture, drive risk management and verification/validation efforts, and guide cross-functional teams toward compliant, high-quality product development and successful lifecycle management.