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Program Manager, Medical Device

Newark, DE, United States

Program Manager – New Product Development (Capital Medical Device Equipment)

**_Location:_** _Newark, DE | Hybrid (Tri-State Area) or Remote (if outside the tri-state area)_

We are seeking an experienced and driven Program Manager to lead new product development (NPD) initiatives for capital medical device equipment. In this high-impact role, you will drive projects from concept through commercialization, collaborating with cross-functional teams to deliver innovative solutions that advance patient care and support our strategic growth.

Key Responsibilities:

+ Lead NPD Programs: Oversee all phases of new product development for capital medical device equipment, from concept, feasibility, and design through to validation, launch, and market introduction.

+ Cross-Functional Leadership: Build and guide high-performing project teams—including R&D, engineering, quality, marketing, manufacturing, and regulatory—ensuring alignment with business objectives and timelines.

+ Strategic Planning: Define program objectives, develop detailed project plans, establish milestones, and coordinate phase/gate reviews to ensure timely and successful program execution.

+ Risk & Change Management: Identify, assess, and proactively manage technical and project risks; facilitate issue resolution and implement course corrections as needed.

+ Stakeholder Engagement: Act as the primary point of contact for program status, facilitating transparent communication with leadership, key stakeholders, and external partners.

+ Resource & Budget Management: Secure and allocate resources, manage project budgets, and ensure effective utilization to meet program deliverables.

+ Product Launch Readiness: Coordinate activities for successful product launch, including transfer to manufacturing, training, and post-launch support plans.

+ Continuous Improvement: Champion best practices in new product development, process optimization, and team collaboration.

Knowledge & Experience:

+ Product Development: Deep understanding of new product development processes for capital medical device equipment, from ideation to launch.

+ Design Controls: Demonstrated experience with FDA and ISO design control requirements throughout the NPD lifecycle.

+ Phase/Gate Methodology: Proficiency in managing projects using phase/gate frameworks and structured decision-making processes.

+ Regulatory & Quality: Solid familiarity with medical device regulatory standards (e.g., FDA 21 CFR 820, ISO 13485) as they apply to product development and market approvals.

+ Market Introduction **:** Experience preparing for and executing successful product launches, including go-to-market strategies and cross-functional readiness.

Skills:

+ Strong project management and organizational skills, with proven ability to lead multiple complex NPD projects simultaneously.

+ Excellent communication and presentation skills, able to engage and influence diverse audiences.

+ Technical proficiency in product development, problem-solving, and data-driven decision-making.

+ Proficiency with Microsoft Office, Microsoft Project, and PPM tools (e.g., Smartsheet, Planview).

Behaviors:

+ Strategic thinker with a proactive, results-driven mindset.

+ Effective collaborator who thrives in cross-functional, fast-paced environments.

+ Agile leader who embraces innovation and continuous improvement.

+ Supportive mentor, fostering a culture of learning and professional growth.

Qualifications:

+ Bachelor’s degree required; Master’s degree preferred (engineering, science, or related field).

+ 8+ years of experience in new product development for medical devices (capital equipment preferred) with a bachelor’s, 6+ years with a master’s, or 3+ years with a PhD.

+ Demonstrated success leading large-scale NPD programs through commercialization.

+ Experience working with global, cross-functional teams.

+ PMP certification is a plus.

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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