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Product Innovation Lead

Caristo Diagnostics - Oxford, Oxfordshire, United Kingdom - In-office - posted 2026-10-13

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Caristo Diagnostics, a University of Oxford spin-out founded in 2018, is a global leader in AI-powered cardiovascular imaging. The company has FDA-approved diagnostic devices (CaRi-Heart® for coronary inflammation, approved July 2026, and a coronary plaque diagnostic approved 2025) and was named a 2026 Technology Pioneer by the World Economic Forum. The Product Innovation Lead will operate within the Research & Innovation Team, bridging research, engineering, operations, clinical, regulatory, and external collaborators to define, prototype, and de-risk future product opportunities before they enter regulated medical device development. Key responsibilities include: **Product Innovation:** Lead development of future product roadmaps and definitions; identify and prioritize features for clinical, commercial, and regulatory success; work closely with engineering to translate prototypes into regulated releases; shape long-term product strategy. **Prototype Development:** Develop and maintain prototype implementations of future capabilities; rapidly evaluate new technical approaches; document methods, validation approaches, and product definitions; establish technical requirements for future releases. **Regulatory & Evidence Generation:** Support validation strategies and evidence-generation plans; help define FDA 510(k) and other regulatory pathways; conduct regulatory dry-runs to identify risks early; generate technical documentation supporting product claims. **Cross-Functional Leadership:** Work across research, engineering, operations, and clinical teams; partner with users to test prototypes in real-world workflows; build alignment around priorities and strategic decisions. **External Collaboration:** Support relationships with collaborators and strategic partners; represent technical programmes in selected discussions; support publications, abstracts, and evidence-generation activities. Success metrics include establishing clear MVP definitions, de-risking regulatory pathways, delivering validated prototype capabilities, creating product evolution roadmaps, building cross-functional relationships, and translating external collaborations into product opportunities. The ideal candidate thrives in ambiguity, builds clarity from incomplete information, works naturally across teams and disciplines, balances near-term delivery with long-term thinking, shares work early, iterates rapidly, and takes ownership without requiring formal authority. The company values judgment, pragmatism, and collaboration over academic perfection. **Requirements:** Essential: - Background in AI, medical imaging, computer vision, or quantitative healthcare technology - Experience developing or evaluating machine learning technologies - Strong scientific and technical reasoning ability - Experience translating research into practical solutions - Ability to work effectively across multiple teams - Strong written and verbal communication skills - Python experience - Experience rapidly prototyping technical concepts - Comfortable making decisions with incomplete information Desirable: - Experience in CT imaging or medical image analysis - Experience working within a regulated healthcare environment - Experience supporting FDA or MDR submissions - Product management or product innovation experience - Experience working with clinicians or clinical operations teams - Experience supporting publications, patents, or conference presentations - Understanding of validation methodologies and clinical evidence generation - Familiarity with modern AI tooling and foundation models

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