Job description

LivaNova is a global medical technology company built on nearly five decades of experience and a relentless commitment to improving the lives of patients around the world. Our advanced technologies and breakthrough treatments provide meaningful solutions for the benefit of patients, healthcare professionals, and healthcare systems. The AI/ML Specialist will be accountable for designing, developing, validating, and maintaining AI/ML solutions that meet healthcare and medical device regulatory requirements. By leveraging state-of-the-art analytical, statistical, and programming methodologies, this role will ensure that deliverables are on time, of high quality, and compliant with applicable regulations. General Responsibilities • Provides AI/ML expertise in medical-use algorithm development & validation and works hands-on on medical-use algorithm development projects across the company's business units. • Contributes to the product strategies and execution for clinical validation and regulatory submissions. • Ensure deliverables adhere to regulatory requirements (e.g., FDA, EU notified bodies) by preparing evidence packages and technical documentation for AI/ML solutions. • Collaborate with Regulatory Affairs to align AI/ML development plans with current and emerging global regulations for medical devices and digital health. • Work with R&D, Clinical, and other stakeholders to identify potential risks, clarify data science requirements, and ensure that AI/ML products meet user needs. • Translate complex AI/ML and data science concepts into clear, concise presentations for both technical and non-technical audiences. • Analyze clinical and non-clinical data, including real-world evidence and post-market surveillance. • Apply predictive modeling, machine learning, and artificial intelligence methods to generate insights and support decision-making for various business units. • Serve as an internal consultant on cutting-edge data science methodologies and best practices, encouraging a culture of continuous improvement and training colleagues on regulatory considerations, AI/ML development lifecycles, and data-driven decision-making. • Maintain compliance with internal procedures (e.g., traceability of changes, data specifications, analysis validation) and the company's quality management system. • Perform other tasks as per line management discretion. Skills and Experience • 6+ years of experience in AI/ML, data science, or related fields, with a track record of deploying solutions in a regulated healthcare or medical device environment. • Previous experience with successful regulatory & clinical strategies to obtain US FDA (or equivalent) approvals of new AI/ML medical-use algorithms. • Adaptable to evolving regulatory landscapes, ensuring that AI/ML solutions remain both innovative and compliant. • Proven track record in designing and implementing ML/AI solutions. • Advanced proficiency in analytics programming languages such as R, Python, SQL, and familiarity with SAS. • Traditional Machine Learning: Time series analysis, unsupervised anomaly detection, analysis of high-dimensional data. • Contemporary data science techniques (e.g. deep learning, reinforcement learning, generative models, and NLP), tools (e.g. Azure Cloud environment), and best practices. • Demonstrated ability to meet timelines, balance multiple projects, and adhere to internal procedures for documentation and quality assurance. • Familiarity with international guidelines, industry standards, and Good Programming Practices; ability to maintain compliance through SOPs, templates, and guidelines. • Excellent interpersonal, written, and verbal communication skills, alongside strong analytical and organizational abilities. • Adept at tackling complex data challenges with innovative solutions. • Experience leading or participating in cross-functional project teams, providing data science guidance, and influencing strategic decisions. Educational Requirements • University degree (at least BSc) with excellent track record in mathematics, statistics, informatics or equivalent. Travel and Work Environment • Occasional travel may be required. Pay Transparency • A reasonable estimate of the annual base salary for this position is $140,000 - $165,000 + discretionary annual bonus.

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