Lead R&D Engineer, AI Applications

Job SummaryThe 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 ResponsibilitiesIdentify, 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 teamsTranslate clinical and workflow needs into well-defined technical problem statements with measurable success criteriaLead technical evaluation of external AI, imaging, and data partners, including definition of evaluation criteria, comparative assessment, and formal recommendations to leadershipManage ongoing vendor relationships, including proof-of-concept scoping, milestone tracking, deliverable review, and issue escalationPartner with Business Development, Legal, and Procurement on statements of work, intellectual property terms, and data ownership and portability provisionsFacilitate cross-functional alignment on AI initiatives across R&D, Clinical, Regulatory Affairs, Quality, and MarketingPrepare and deliver technical and strategic recommendations to divisional leadership and the Steering CommitteeCollaborate 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 devicesDefine requirements for training, validation, and test datasets, including data sourcing, annotation processes, and dataset governanceEnsure AI and ML components are integrated into existing design control, risk management (ISO 14971), software lifecycle (IEC 62304), and cybersecurity processesProvide technical guidance and mentorship to engineering staff on AI and computer vision methods, evaluation practices, and industry developmentsMonitor the external landscape of AI technologies, standards, and competitive products relevant to the division's product portfolioPerform other duties as assignedQualificationsEducationBachelor's degree in Computer Science, Electrical Engineering, Biomedical Engineering, or a related technical field requiredMaster's degree or PhD preferredExperienceMinimum 8 years of engineering experience in medical devices, medical imaging, or a comparable FDA-regulated industryMinimum 3 years of direct experience developing, evaluating, or integrating AI or computer vision technologiesDemonstrated experience managing external technology vendors or development partners through evaluation, contracting, and deliveryExperience working within a design controls environment and with FDA regulatory pathways (510(k), De Novo)Experience presenting technical recommendations to senior leadershipPreferredExperience with ultrasound, endoscopy, or other intra-procedural imaging modalitiesDirect involvement in a regulatory submission for an AI- or ML-enabled device featureExperience with clinical data collection, annotation workflows, and dataset managementFamiliarity with real-time or embedded imaging system architecturesWorking knowledge of IEC 62304, ISO 14971, IEC 60601, and FDA Good Machine Learning Practice principlesSkills and CompetenciesSufficient technical depth in machine learning and computer vision to critically assess vendor claims, model performance data, and validation reportsStrong cross-functional leadership and facilitation skills, with the ability to drive decisions across engineering, clinical, and business functionsClear written and verbal communication, with the ability to adapt content for executive, clinical, and engineering audiencesStrategic thinking with the ability to balance technical feasibility, clinical value, regulatory burden, and business prioritiesNegotiation skills and sound judgment in commercial and intellectual property discussionsAbility to operate independently in ambiguous environments and establish structure where neededTravelUp to 15% domestic and international travel to partner sites, clinical locations, and industry events.Work Environment and Physical RequirementsStandard office and laboratory environment. Occasional work in engineering labs with medical device prototypes and imaging equipment.Equal Opportunity StatementHologic 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. If you have the right skills and experience and want to join our team, apply today. We can’t wait to hear from 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.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.#LI-RT1Full timePosting Date: 2026-08-27