AI/ML Specialist, Livanova
$140-165k
+ Discretionary annual bonus + Employee Stock Purchase Plan
More information about location
Global medical technology company
Open for applications
Global medical technology company
1001+ employees
Open for applications
$140-165k
+ Discretionary annual bonus + Employee Stock Purchase Plan
More information about location
1001+ employees
Company mission
To provide hope for patients and their families through innovative medical technologies, delivering life-changing improvements for both the Head and Heart.
Role
Who you are
- 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
- University degree (at least BSc) with excellent track record in mathematics, statistics, informatics or equivalent
- Occasional travel may be required
What the job involves
- 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
- 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
Our take
Though only formed in 2015, LivaNova’s history in the medical space stretches back to the founding of Sorin Biomedica in 1956, which merged with Cyberonics to form LivaNova. Combining their specialties in cardiovascular disease and neuromodulation, LivaNova has remained at the forefront of innovation in therapeutic areas affecting the head and heart.
The company creates advanced medical devices and treatments in areas like cardiopulmonary care and neuromodulation, helping both patients and healthcare professionals worldwide. With its diverse range of products and a presence in over 100 countries, LivaNova is well-positioned as a leader in the field, continuously striving to improve the lives of those who need it most.
Recently, LivaNova has made waves with its new treatment for obstructive sleep apnea (OSA), a condition where breathing stops and starts during sleep. Its device, the aura6000, has shown promising results in a major clinical trial. This breakthrough could change the way OSA is treated, and the trial results were strong enough for LivaNova to consider moving forward with approval from the FDA. If successful, the aura6000 could become a major competitor in the sleep apnea market, positioning LivaNova for exciting growth in a new and expanding field.
Kirsty
Company Specialist at Welcome to the Jungle
Insights
Company
Company HQ
Paddington, London, UK
Leadership
Vladimir Makatsaria
(CEO)Previously spent over 27 years at Johnson & Johnson, while there they served in various roles, including Company Group Chairman of Ethicon Global Business, Chairman of China, and Global Integration Leader among other roles.
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