Eng Specialist, Software

• Develop and deploy AI/ML models that calculate clinical limits for infusion therapy executed with Infusion Pumps based on historical data of previous infusions
• Collaborate with cross-functional teams, including clinicians, engineers, and product managers, to understand clinical needs and develop models that meet those needs

Ensure models are compliant with regulatory requirements, including but not limited to:

• FDA guidelines for Software as a Medical Device (SaMD)
• CE marking requirements
• ISO 13485:2016

• Analyze large datasets of historical infusion therapy data to identify patterns and trends

Interpret results of AI/ML model development and deployment, including but not limited to:

• Model performance metrics (eg, accuracy, precision, recall)
• Model interpretability (eg, feature importance, partial dependence plots)

• Collaborate with clinicians and engineers to understand the clinical implications of model results

• Deploy AI/ML models in a software as a medical device (SaMD) product, ensuring compliance with regulatory requirements
• Monitor model performance and update models as needed to maintain accuracy and relevance
• Collaborate with the development team to integrate models into the product, ensuring seamless user experience

• Develop data visualizations to communicate complex model outputs to clinicians and other stakeholders
• Create reports and dashboards to track model performance and identify areas for improvement
• Present findings and recommendations to cross-functional teams, including clinicians, engineers, and product managers

Ensure compliance with regulatory requirements, including but not limited to:

• FDA guidelines for SaMD
• CE marking requirements
• ISO 13485:2016

• Collaborate with the quality assurance team to ensure model development and deployment meet regulatory requirements

• Lead cross-functional teams, including data scientists, engineers, and clinicians, to develop and deploy AI/ML models
• Collaborate with clinicians and engineers to understand clinical needs and develop models that meet those needs
• Participate in cross-functional teams to ensure model development and deployment meet business objectives

• 16+ years of experience in data science, machine learning, or a related field

Strong background in programming languages, including but not limited to:

• Python
• R
• SQL

Experience with AI/ML frameworks, including but not limited to:

• TensorFlow
• PyTorch
• Scikit-learn

Experience with data visualization tools, including but not limited to:

• Tableau
• Power BI
• D3.js

• Strong analytical and problem-solving skills
• Excellent communication and collaboration skills
• Ability to work in a fast-paced environment with multiple priorities
• Experience with regulatory requirements for SaMD
• Familiarity with ISO 13485:2016 and FDA guidelines for SaMD