Lead Product Development Engineer, R&D

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

Lead Product Development Engineer

We are seeking a Lead Product Development Engineer to drive the design, development, verification, validation, and commercialization of innovative medical devices from concept through launch and sustaining transfer.

In this role, you will serve as a technical leader on cross‑functional product development teams, translating customer, clinical, and business needs into robust, manufacturable, and compliant product solutions. You will lead complex engineering programs, guide technical decision‑making, and ensure project objectives are achieved across quality, cost, performance, schedule, manufacturability, and regulatory compliance.

This is an opportunity for an experienced engineer who thrives in a highly collaborative, regulated environment and is passionate about developing products that improve patient and clinician experiences.

What You’ll Do

• Lead large, technically complex product development projects, including the development and integration of multiple subsystem architectures.
• 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.

What We’re Looking For

Education & Experience

• 8+ years of relevant experience with a non‑technical degree, or
• 6+ years of relevant experience with a Master’s degree, or
• 3+ years of relevant experience with a PhD.

Product development experience in regulated medical devices or similarly regulated industries strongly preferred.

Required Experience

• 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 without direct authority.
• 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.
• Strong understanding of manufacturing processes such as machining, injection molding, joining methods, and rapid prototyping.
• Experience with root cause investigation, design for reliability, supplier development, project management, and risk‑based decision‑making.
• Experience with agile or phase‑gate product development processes.
• Knowledge of human factors engineering and usability principles.
• Strong experimental, computational, and analytical skills, including DFSS tools, statistical methods, DOE, and MiniTab.
• Proficiency with tolerance stack‑ups, DFM, and GD&T.
• CAD expertise; SolidWorks preferred.
• Excellent verbal and written communication skills, with the ability to tailor communication for both technical and non‑technical audiences.
• Strong presentation skills and the ability to clearly communicate complex technical information.
• Creativity, initiative, vision, and a continuous improvement mindset.

The annualized base salary range for this role is $119,300 - $186,600 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, geography, education, business needs and market demand.

Location: Marlborough, MA, United States

Hologic, Inc. is proud to be an Equal Opportunity Employer inclusive of disability and veterans.