AI/ML Specialist

Join us today and make a difference in people's lives!

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 company is listed on the NASDAQ stock exchange under the ticker symbol " LIVN ." LivaNova is headquartered in London (UK) with a presence in over 100 countries and a team of more than 3,000 employees worldwide.

Position Summary:

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. In close collaboration with cross-functional teams-including Regulatory Affairs, Clinical, R&D, and other Data Scientists-this individual will play a pivotal role in guiding regulatory strategies, shaping product roadmaps, and achieving timely regulatory approvals for AI/ML-based products. The AI/ML Specialist has a global scope and supports all business units.

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 innovation.

• Mentor and train 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. This experience may come either from direct experience at FDA or from several successful applications approved/cleared by FDA.

• 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.

• Mastery of contemporary data science techniques (e.g. deep learning, reinforcement learning, generative models, and NLP), tools (e.g. Azure Cloud environment), and best practices, with a track record of delivering high-impact solutions including regulatory submissions or digital product launches.

• 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.

Education:

• University degree (at least BSc) with excellent track record in mathematics, statistics, informatics or equivalent.

Travel Requirements:

• 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. Pay ranges may vary by location.

Employee benefits include:

• Health benefits - Medical, Dental, Vision

• Personal and Vacation Time

• Retirement & Savings Plan (401K)

• Employee Stock Purchase Plan

• Training & Education Assistance

• Bonus Referral Program

• Service Awards

• Employee Recognition Program

• Flexible Work Schedules

Valuing different backgrounds:

LivaNova values equality and diversity. We are committed to ensuring that our recruitment process is fair, transparent and free from unlawful discrimination. Our selection process is driven by the key demands/requirements for the role rather than bias or discrimination on the basis of a candidate's sex, gender identity, age, marital status, veteran status, non-job-related disability/handicap or medical condition, family status, sexual orientation, religion, color, ethnicity, race or any other legally protected classification.

Notice to third party agencies:

Please note that we do not accept unsolicited resumes from recruiters or employment agencies. In the absence of a signed Recruitment Services Agreement, we will not consider, or agree to, payment of any referral compensation or recruiter fee. In the event that a recruiter or agency submits a resume or candidate without a previously signed agreement, we explicitly reserve the right to pursue and hire those candidate(s) without any financial obligation to the recruiter or agency.

Beware of Job Scams:

Please beware of potentially fraudulent job postings or suspicious recruiting activity by persons posing as LivaNova recruiters or employees. The scammers may attempt to solicit confidential, personal information, such as a social security number, or your financial information. LivaNova will never ask for fees prior/during/after the application process, nor will we ask for banking details or personal financial information in return for the assurance of employment. If you are concerned that an offer of employment might be a scam or that the recruiter is not legitimate, please verify by searching for "See Open Jobs" on https://www.livanova.com/en-us/careers, and check that all recruitment emails come from an @livanova.com email address.