Lead Systems Engineer, Medical Device

Are you a strategic thinker, problem solver, and visionary leader ready to shape the future of medical device innovation? Join Hologic as our Lead Systems Engineer, R&D, and play a pivotal role in developing cutting-edge products that transform patient care.

What You’ll Do :

Lead cross-functional teams on large, complex, and technically challenging product development projects, driving the full design life cycle from concept to commercialization.

Maintain and expand expert-level understanding of our products and their clinical applications.

Define and communicate a shared vision and roadmap for product development, research, and sustaining activities.

Drive high-level architectural discussions, conceptualizing, designing, and developing solutions for clinical, workflow, and visualization needs—especially in radiology.

Oversee product roadmaps and make effective tradeoffs between competing priorities.

Collaborate with Product Management, Marketing, Regulatory, SQA, and other functions to deliver product value and ensure alignment with customer and business needs.

Continuously study the market, engage with customers, and integrate feedback to ensure products meet market demands and user expectations.

Lead requirements definition, documentation, and feature development, always representing the voice of the end user.

Provide technical leadership in CAPA, NCE, audit processes, and post-market surveillance.

Foster a culture of continuous improvement, best practice sharing, and knowledge growth across the organization.

Build collaborative relationships with internal and external stakeholders; regularly travel to customer sites for direct insights.

Contribute to company innovation through invention and patent applications.

Experience & Qualifications :

Bachelor’s degree required; Master’s or PhD preferred in a technical discipline.

8+ years of relevant experience (or 6+ years with Master’s, 3+ with PhD) in engineering, product development, or related field.

Proven track record leading complex projects and cross-functional teams in medical device R&D.

Strong knowledge of FDA regulations, ISO standards (e.g., ISO 14971, IEC 60601, IEC 62304), GMP, and design controls.

Key Skills :

Expert-level technical understanding of medical device products and clinical applications.

In-depth engineering expertise across multiple disciplines; clinical and technical experience in medical imaging technologies a plus.

Strategic thinking and strong analytical, problem-solving, and decision-making skills.

Exceptional communication, influence management, and storytelling abilities—able to engage technical and non-technical audiences.

Ability to build and maintain positive relationships across a matrix organization and with external stakeholders.

Strong leadership, mentoring, and feedback skills; adept at fostering an engaged and collaborative culture.

Demonstrated creativity, resourcefulness, initiative, and vision in developing innovative products and solutions.

Ability to direct, coordinate, and motivate cross-functional teams to achieve project goals.

Physical Demands & Travel :

Ability to sit, stand, walk, reach, stoop, kneel, and lift / move up to 40 pounds.

Regular travel to customer sites and industry events as required.

Why Hologic?

Lead innovation in life-changing medical technologies.

Collaborate with top talent in a mission-driven environment.

Make a measurable impact on patient care and business outcomes.

So why join Hologic?

We are committed to making Hologic the company where top talent comes to grow. For you to succeed, we want to enable you with the tools and knowledge required and so we provide comprehensive training when you join as well as continued development and training throughout your career. We offer a competitive salary and annual bonus scheme, one of our talent partners can discuss this in more detail with you.

If you have the right skills and experience and want to join our team, apply today. We can’t wait to hear from you!

The annualized base salary range for this role is $114,800 - $179,500 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, geography, education, business needs and market demand.

Agency and Third-Party Recruiter Notice : Agencies that submit a resume to Hologic must have a current executed Hologic Agency Agreement executed by a member of the Human Resource Department. In addition Agencies may only submit candidates to positions for which they have been invited to do so by a Hologic Recruiter. All resumes must be sent to the Hologic Recruiter under these terms or they will not be considered.

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

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