(US) Edge AI Product Owner - Medical Devices & AI

Job Description: Edge AI Product Owner - Medical Devices & AI

Experience Level: 5-8 Years

Department: Product, Data and AI Engineering

About the Role:

We are seeking a visionary and technically adept Edge AI Product Owner to lead the development and lifecycle management of cutting-edge Edge AI solutions in the MedTech domain. This role requires a deep understanding of medical device compliance, AI technologies, and product strategy to deliver impactful and regulatory-compliant solutions.

Key Responsibilities:

- Define and drive the product vision, roadmap, and strategy for Edge AI-enabled medical devices.

- Collaborate with cross-functional teams including engineering, clinical, regulatory, and quality to ensure product alignment and compliance.

- Oversee the development and integration of computer vision and video-based AI algorithms into edge devices.

- Ensure adherence to SaMD classification, regulatory frameworks (e.g., FDA, MDR), and quality processes.

- Lead verification and validation planning and execution for Edge AI products.

- Gather and prioritize customer and stakeholder requirements to inform product decisions.

- Communicate product goals, progress, and risks effectively to internal and external stakeholders.

- Support test data validation and performance evaluation of AI models deployed on edge devices.

Required Qualifications:

- Bachelor's or Master's degree in Engineering, Computer Science, Biomedical Engineering, or related field.

- 5-8 years of experience in product management or ownership, preferably in medical devices or healthcare technology.

- Strong understanding of Edge AI systems, including device architecture, model deployment, and performance optimization.

- Experience with computer vision and video-based AI technologies.

- Familiarity with SaMD regulations, ISO 13485, IEC 62304, and related standards.

- Proven track record in managing regulated software products through the full product lifecycle.

- Excellent verbal and written communication skills.

- Experience with agile methodologies and product management tools.

Preferred Skills:

- Experience with surgical AI applications and edge device integration.

- Knowledge of risk management processes (ISO 14971, 510).

- Familiarity with cloud platforms (AWS, Azure) and CI/CD pipelines.

- Understanding of data privacy and cybersecurity standards in healthcare.