Lead Medical Device Innovation Engineer

Hologic, Inc.; Marlborough (MA); On-site; USD 119,300 - 186,600; Full time

Job summary

Hologic, Inc. seeks a Lead Product Development Engineer to drive design, verification, validation, and commercialization of innovative medical devices from concept through launch.

You will lead cross‑functional teams, translate clinical and business needs into robust product solutions, and ensure regulatory compliance, manufacturability, and scalable transfer to production. This role requires extensive experience in regulated medical device development and systems engineering.

Qualifications

• Experience leading regulated medical device development programs.
• Knowledge of FDA QSR, ISO 13485, design controls, risk management.

Responsibilities

• Lead large, technically complex product development projects and integrate multiple subsystem architectures.
• Provide technical leadership to cross‑functional teams including engineering, marketing, quality, regulatory, and manufacturing.
• Translate user needs into product requirements, specifications, and system architecture.
• Drive design verification/validation activities and design transfer to production.
• Direct risk management activities per ISO 14971 and ensure traceability throughout the lifecycle.
• Mentor peers and drive continuous improvement in methods, tools, and processes.

Skills

Cross-functional leadership

Regulatory compliance

DFSS tools

DOE

Risk management

System engineering

Analytical skills

Troubleshooting

Education

Master’s degree

PhD

Non‑technical degree, 8+ years

Tools

SolidWorks

Job description

Hologic, Inc. seeks a Lead Product Development Engineer to drive design, verification, validation, and commercialization of innovative medical devices from concept through launch.

You will lead cross‑functional teams, translate clinical and business needs into robust product solutions, and ensure regulatory compliance, manufacturability, and scalable transfer to production. This role requires extensive experience in regulated medical device development and systems engineering.