4 дня назад
AI/ML Computer Vision Lead (Medical Devices)
128 200 - 200 500$
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
AI/ML Computer Vision Lead (Medical Devices): Identifying, evaluating, and integrating AI and computer vision capabilities into GYN surgical platforms and imaging systems with an accent on clinical value, vendor evaluation, and FDA-regulated product development. Focus on defining datasets and validation processes, integrating machine learning components into design controls and risk management, and shaping regulatory strategies for AI-enabled medical device features.
Location: Marlborough, Massachusetts, United States; standard office and laboratory environment with occasional work around medical device prototypes and imaging equipment. Travel: Up to 15% domestic and international travel.
Annual base salary: $128,200–$200,500, plus bonus eligibility.
Company
develops medical device and imaging solutions, including platforms for gynecological surgical procedures.
What you will do
- Identify, assess, and prioritize AI and computer vision opportunities across GYN surgical capital platforms, ultrasound-guided fibroid ablation systems, hysteroscopy consoles, and imaging systems.
- Translate clinical and workflow needs into technical problem statements with measurable success criteria.
- Evaluate external AI, imaging, and data partners; manage proof-of-concepts, milestones, deliverables, escalations, and vendor relationships.
- Coordinate with Business Development, Legal, Procurement, R&D, Clinical, Regulatory Affairs, Quality, Marketing, and Engineering teams.
- Define training, validation, and test dataset requirements, including data sourcing, annotation, and governance.
- Guide regulatory and product integration activities for AI-enabled features and present recommendations to divisional leadership and steering committees.
Requirements
- Bachelor’s degree in Computer Science, Electrical Engineering, Biomedical Engineering, or a related technical field.
- At least 8 years of engineering experience in medical devices, medical imaging, or another FDA-regulated industry.
- At least 3 years of direct experience developing, evaluating, or integrating AI or computer vision technologies.
- Experience managing external technology vendors or development partners through evaluation, contracting, and delivery.
- Experience with design controls, FDA regulatory pathways such as 510(k) and De Novo, and presenting technical recommendations to senior leadership.
- Technical depth in machine learning and computer vision, plus knowledge of risk management, software lifecycle, and cybersecurity processes.
Nice to have
- Master’s degree or PhD in a relevant technical field.
- Experience with ultrasound, endoscopy, intra-procedural imaging, or real-time embedded imaging architectures.
- Involvement in regulatory submissions for AI- or ML-enabled device features.
- Experience with clinical data collection, annotation workflows, and dataset management.
- Knowledge of IEC 62304, ISO 14971, IEC 60601, and FDA Good Machine Learning Practice principles.
Culture & Benefits
- Comprehensive onboarding, continued professional development, and training throughout the career.
- Competitive salary and annual bonus eligibility.
- Opportunity to work across engineering, clinical, regulatory, quality, marketing, and business functions.
- Work includes office, laboratory, partner-site, clinical-location, and industry-event environments.
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