Lead AI Applications Engineer - Medical Imaging & R&D

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

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