Senior Lead Medical Device Product Development Engineer

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

Job summary

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

You will lead cross-functional teams, translate customer and clinical needs into robust product solutions, and ensure regulatory compliance throughout the lifecycle. This role requires strong technical leadership and collaboration across engineering, quality,

Qualifications

• Demonstrated expertise in FDA Quality System Regulation, ISO 13485, design controls, risk management, verification and validation, and design transfer.
• Proven ability to lead cross-functional product development programs and influence stakeholders.
• Strong technical leadership, decision-making, and problem-solving skills.
• Ability to rapidly develop deep technical and clinical understanding of complex medical device products.
• Broad engineering knowledge across disciplines, with experience in systems engineering and product architecture.

Responsibilities

• Lead large, technically complex product development projects.
• Provide technical leadership to cross-functional teams across engineering, marketing, quality, regulatory, manufacturing, clinical, and external partners.
• Translate user needs, clinical insights, and market requirements into product requirements, technical specifications, system architecture, and design outputs.
• Lead design control activities, ensuring documentation, traceability, and compliance throughout the product lifecycle.
• Drive risk management activities in accordance with ISO 14971, including hazard analysis, risk evaluation, mitigation planning, and verification of risk controls.
• Lead requirements decomposition, system architecture development, and integration across mechanical, electrical, software, and disposable subsystem designs.
• Partner with clinicians, customers, and marketing teams to identify unmet needs and develop differentiated product solutions.
• Support human factors engineering and usability activities to help ensure safe, effective, and intuitive product performance.
• Lead design verification, validation, and engineering documentation, including engineering reports, test plans, and V&V deliverables.
• Lead design transfer activities, ensuring products are manufacturable, scalable, validated, and effectively transferred into production.
• Manage technical project success factors including progress, scope, schedule, budget, risks, resources, and capability gaps.
• Facilitate technical project meetings, present recommendations, and support data-driven decision-making.
• Solve complex technical problems requiring broad engineering expertise and sound judgment.
• Collaborate cross-functionally to improve methods, tools, processes, and product development outcomes.
• Mentor peers and team members, supporting technical development, learning, and knowledge transfer.
• Champion continuous improvement and stay current with emerging technologies, tools, and engineering practices.

Skills

Technical leadership

Cross-functional leadership

Strong communication

Problem solving

Regulatory knowledge

Decision making

Systems engineering

Agile / phase-gate

Human factors engineering

Design for reliability

Education

Bachelor's degree

Master's degree

PhD

Tools

SolidWorks

MiniTab

Job description

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

You will lead cross-functional teams, translate customer and clinical needs into robust product solutions, and ensure regulatory compliance throughout the lifecycle. This role requires strong technical leadership and collaboration across engineering, quality,