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

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Written by AI from the job title and company, not by Mayo Clinic School of Health Sciences, so some details may not match this job. The employer's own page has the real description.

Job Overview

The Senior AI/ML Engineer at Mayo Clinic School of Health Sciences will be responsible for developing and maintaining software as a medical device (SaMD) solutions, leveraging advanced artificial intelligence and machine learning methodologies. This role requires collaboration with cross-functional teams to ensure that all SaMD products meet quality and regulatory standards. The candidate will contribute to the end-to-end development life cycle, from conceptual design to post-launch evaluation, ensuring adherence to SaMD regulatory requirements and design quality assurance protocols.

Job Responsibilities

• Design, develop, and implement AI/ML algorithms for SaMD applications.
• Collaborate with product management and regulatory teams to ensure compliance with healthcare regulations.
• Conduct thorough testing and validation of AI/ML models to ensure reliability and effectiveness.
• Utilize data analysis techniques to derive insights and improve the performance of SaMD products.
• Provide technical guidance and mentorship to junior engineers in the team.
• Document design processes, algorithms, and regulatory compliance for project audits.
• Stay current with healthcare trends, technologies, and regulatory changes related to SaMD.

Qualifications

• Master’s or Ph.D. degree in Computer Science, Engineering, Mathematics, or a related field.
• 5+ years of experience in AI/ML model development, preferably in a healthcare setting.
• Strong programming skills in languages such as Python, R, or Java.
• Proficiency with machine learning frameworks (e.g., TensorFlow, PyTorch, Scikit-learn).
• Experience with software development lifecycle and agile methodologies.
• Familiarity with SaMD regulations and quality standards (ISO 13485, IEC 62304, FDA guidelines).
• Excellent communication and interpersonal skills.

Technologies & Tools

The Senior AI/ML Engineer will utilize a variety of technologies and tools including, but not limited to, cloud platforms such as AWS or Azure for data storage and processing, data visualization software like Tableau, and version control systems such as Git for project management. Familiarity with medical device software validation tools and data management systems is essential for ensuring that products meet regulatory requirements.

Ideal Candidates

The ideal candidate for this position will possess a combination of technical expertise, innovative thinking, and a passion for improving healthcare through technology. They should demonstrate strong problem-solving abilities and a commitment to quality and safety in medical device development. Excellent communication skills, a collaborative working style, and the ability to adapt to rapidly changing requirements are essential traits to succeed in this dynamic environment.