AI/ML Engineer - SaMD System Engineering & Design Quality - CDH - Remote

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Job Overview

The AI/ML Engineer for SaMD System Engineering & Design Quality at Mayo Clinic will play a pivotal role in advancing the development and implementation of Software as a Medical Device (SaMD) solutions. This position requires expertise in artificial intelligence and machine learning, coupled with a strong foundation in engineering practices and quality assurance. The ideal candidate will work collaboratively with cross-functional teams to ensure the design, development, and deployment processes meet stringent regulatory guidelines and quality standards, ultimately contributing to improved healthcare outcomes.

Job Responsibilities

• Develop and implement AI/ML models to support SaMD applications in healthcare.
• Conduct risk assessments and ensure compliance with relevant regulations, standards, and guidelines.
• Collaborate with software engineers and quality assurance teams to integrate AI/ML capabilities within existing systems.
• Design and execute validation protocols to ensure the accuracy and effectiveness of AI models.
• Participate in the drafting and reviewing of technical documentation and design controls.
• Work on Continuous Improvement initiatives by analyzing AI/ML performance metrics and identifying enhancement opportunities.
• Stay updated on advancements in AI/ML technologies and their applications in medical devices.

Qualifications

• Bachelor’s degree in Computer Science, Engineering, or a related field; Master’s degree preferred.
• 3+ years of experience in AI/ML engineering in a healthcare or technology environment.
• Strong understanding of machine learning algorithms, data analysis, and statistical modeling.
• Experience with regulatory compliance, particularly related to SaMD, ISO 13485, and FDA regulations.
• Proficiency in programming languages such as Python or R, and familiarity with ML frameworks like TensorFlow or PyTorch.
• Excellent problem-solving skills and the ability to work independently as well as in a collaborative team environment.

Technologies & Tools

The ideal candidate will be proficient in a variety of technologies and tools essential for AI/ML engineering. This includes, but is not limited to, programming languages like Python, data processing frameworks such as TensorFlow and PyTorch, and tools for data visualization and analytics. Familiarity with cloud platforms (e.g., AWS, Azure) for deploying ML models and tools for managing software development lifecycle (e.g., Git, Jenkins) will be highly advantageous.

Ideal Candidates

The ideal candidate will embody a strong blend of technical expertise and soft skills, showcasing a passion for innovation in healthcare technology. They are detail-oriented, with a keen ability to understand complex systems and solve multifaceted problems. Their proactive approach to collaboration and communication allows them to thrive in a dynamic team environment while keeping patient outcomes as their focal point. Additionally, a continuous learning mindset and adaptability to evolving technologies and regulatory frameworks are paramount for success in this role.