Senior Medical Device Product Development Lead

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

Job summary

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

You will guide cross-functional teams to translate clinical needs into robust, manufacturable solutions and ensure regulatory compliance across the product lifecycle. This role requires leadership in design controls, risk management per ISO 14971, and collaboration with clinicians, marketing, quality,

Qualifications

• Bachelor’s degree required; Master’s degree preferred.
• Regulated medical device product development experience is strongly preferred.
• Experience with FDA Quality System Regulation, ISO 13485, design controls, risk management, verification and validation, and design transfer.

Responsibilities

• Lead large, technically complex product development projects across multiple subsystems.
• Provide technical leadership to cross-functional teams (engineering, marketing, quality, regulatory, manufacturing, clinical, external partners).
• Translate user needs into product requirements, specifications, and architecture.
• Lead design control activities with documentation, traceability, and lifecycle compliance.
• Drive risk management per ISO 14971, including hazard analysis and validation.
• Manage design transfer to production and scalability.
• Mentor peers and drive continuous improvement.

Skills

Cross-functional leadership

Design controls

Risk management

FDA Quality System Regulation

ISO 13485

Verification & Validation

Design transfer

DFSS tools

DOE

MiniTab

GD&T

CAD

SolidWorks

Technical communication

Education

Bachelor’s degree

Master’s degree

PhD

Tools

SolidWorks

Job description

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

You will guide cross-functional teams to translate clinical needs into robust, manufacturable solutions and ensure regulatory compliance across the product lifecycle. This role requires leadership in design controls, risk management per ISO 14971, and collaboration with clinicians, marketing, quality,