Lead R&D Engineer, AI Applications

DIRECT SALES, US; Marlboro (MA); On-site; USD 128,000 - 201,000; Full time

Benefits offered by this job

Competitive salary

Annual bonus

Job summary

Hologic is seeking a Lead Engineer, AI Applications to drive AI and computer vision across GYN Surgical platforms, interfacing with R&D, regulatory, and marketing teams. The role shapes the division's AI roadmap, manages external partners, and ensures compliance with regulatory and design controls throughout development.

The successful candidate has 8+ years in medical devices or imaging, 3+ years in AI/cv, and proven vendor-management experience with the ability to present strategic

Qualifications

• Minimum 8 years in medical devices, medical imaging, or a FDA-regulated industry.
• Minimum 3 years developing, evaluating, or integrating AI or computer vision tech.
• Demonstrated experience managing external technology vendors through evaluation, contracting, and delivery.
• Experience with design controls and FDA regulatory pathways (510(k), De Novo).

Responsibilities

• Identify, assess, and prioritize opportunities to apply AI and computer vision within GYN procedures.
• Translate clinical needs into well-defined technical problem statements.
• Lead external AI, imaging, and data partner evaluations with formal leadership recommendations.
• Partner with Legal and Procurement on statements of work and IP terms.
• Ensure AI/ML components align with ISO 14971, IEC 62304, and cybersecurity processes.

Skills

AI & computer vision

cross-functional leadership

regulatory compliance

vendor management

FDA regulatory pathways

Education

Bachelor's degree in Computer Science/Electrical/Biomedical Eng

Master's or PhD preferred

Tools

Design controls

FDA regulatory knowledge

IEC 62304

ISO 14971

Job description

Job Summary

The Lead Engineer, AI Applications leads the identification, evaluation, and integration of artificial intelligence and computer vision capabilities across Hologic's GYN Surgical capital platforms, including ultrasound-guided fibroid ablation, hysteroscopy consoles, and associated imaging and visualization systems. This role serves as the primary technical and strategic interface between internal R&D teams, external AI and imaging technology partners, and cross-functional stakeholders in Clinical, Regulatory, Quality, Marketing, and Business Development. The position is responsible for shaping the division's AI application roadmap, managing external vendor engagements from evaluation through productization, and ensuring AI-enabled features are developed in compliance with applicable regulatory and design control requirements.

Essential Duties and Responsibilities

• Identify, assess, and prioritize opportunities to apply AI and computer vision within GYN surgical procedures and capital equipment, in collaboration with software, systems, and clinical engineering teams
• Translate clinical and workflow needs into well-defined technical problem statements with measurable success criteria
• Lead technical evaluation of external AI, imaging, and data partners, including definition of evaluation criteria, comparative assessment, and formal recommendations to leadership
• Manage ongoing vendor relationships, including proof-of-concept scoping, milestone tracking, deliverable review, and issue escalation
• Partner with Business Development, Legal, and Procurement on statements of work, intellectual property terms, and data ownership and portability provisions
• Facilitate cross-functional alignment on AI initiatives across R&D, Clinical, Regulatory Affairs, Quality, and Marketing
• Prepare and deliver technical and strategic recommendations to divisional leadership and the Steering Committee
• Collaborate with Regulatory Affairs to define submission strategy for AI-enabled features, including predicate identification, predetermined change control plans, and alignment with FDA guidance on AI/ML-enabled medical devices
• Define requirements for training, validation, and test datasets, including data sourcing, annotation processes, and dataset governance
• Ensure AI and ML components are integrated into existing design control, risk management (ISO 14971), software lifecycle (IEC 62304), and cybersecurity processes
• Provide technical guidance and mentorship to engineering staff on AI and computer vision methods, evaluation practices, and industry developments
• Monitor the external landscape of AI technologies, standards, and competitive products relevant to the division's product portfolio
• Perform other duties as assigned

Qualifications

Education

• Bachelor's degree in Computer Science, Electrical Engineering, Biomedical Engineering, or a related technical field required
• Master's degree or PhD preferred

Experience

• Minimum 8 years of engineering experience in medical devices, medical imaging, or a comparable FDA-regulated industry
• Minimum 3 years of direct experience developing, evaluating, or integrating AI or computer vision technologies
• Demonstrated experience managing external technology vendors or development partners through evaluation, contracting, and delivery
• Experience working within a design controls environment and with FDA regulatory pathways (510(k), De Novo)
• Experience presenting technical recommendations to senior leadership

Preferred

• Experience with ultrasound, endoscopy, or other intra-procedural imaging modalities
• Direct involvement in a regulatory submission for an AI- or ML-enabled device feature
• Experience with clinical data collection, annotation workflows, and dataset management
• Familiarity with real-time or embedded imaging system architectures
• Working knowledge of IEC 62304, ISO 14971, IEC 60601, and FDA Good Machine Learning Practice principles

Skills and Competencies

• Sufficient technical depth in machine learning and computer vision to critically assess vendor claims, model performance data, and validation reports
• Strong cross-functional leadership and facilitation skills, with the ability to drive decisions across engineering, clinical, and business functions
• Clear written and verbal communication, with the ability to adapt content for executive, clinical, and engineering audiences
• Strategic thinking with the ability to balance technical feasibility, clinical value, regulatory burden, and business priorities
• Negotiation skills and sound judgment in commercial and intellectual property discussions
• Ability to operate independently in ambiguous environments and establish structure where needed

Travel

Up to 15% domestic and international travel to partner sites, clinical locations, and industry events.

Work Environment and Physical Requirements

Standard office and laboratory environment. Occasional work in engineering labs with medical device prototypes and imaging equipment.

Equal Opportunity Statement

Hologic is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

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.

Additional Info

The annualized base salary range for this role is $128,200 - $200,500 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, geography, education, business needs and market demand.