Digital Health Platform & SaMD Prototype Lead

Description

TheDigital Health Platform & SaMD Prototype Leaddefines the DNA of how Takeda designs for the future of digital health.

This role establishes the system through which all creative disciplines — from brand voice to cognitive-system interaction — work coherently, safely, and humanely. By embedding artificial intelligence, rapid prototyping, and SaMD-ready regulatory frameworks into anagile,GxP-compliant design ecosystem, it enables the creation of empathetic, intelligent, and compliant medical experiencesatscale.

The Head oversees the strategy, system architecture, and operationalization of AI-integrated, human-centered design frameworks within the Digital Health Platform. Working closely with product, engineering, regulatory, clinical, and data science partners, this role ensures that intelligent experiences are clinically meaningful, ethically sound, and compliant with global SaMD,GxP, and AI regulations — while fostering a culture of agility, co-creation, and continuous innovation.

Key Responsibilities

AI Design & Rapid Prototyping

• Lead the conceptualization and rapid prototyping of AI-driven and cognitive features for both SaMD and non-SaMD digital health products.

• Ensure AI and intelligent features are explainable, ethical, and human-centered, aligned with medical standards and clinical value.

• Establish systemic frameworks for iterative prototyping, testing, and validation — accelerating innovation whilemaintainingdesign control, traceability, andGxPcompliance.

• Partner with clinical, data science, and UX teams to design evidence-based intelligent interactions that integrate seamlessly with clinical workflows.

Design Systems & Experience Architecture

• Build andmaintainasafety-aware, AI-ready design systemthat unifies content, brand, and interface guidelines with regulatory,GxP, and usability metadata.

• Define reusable patterns and templates that encode human factors, compliance, and cognitive ergonomics by design.

• Integrate design systems directly into the digital health platform architecture to ensurescalability, traceability, and audit-readinessacross multiple product teams.

Cognitive Experience & Human Factors Integration

• Develop frameworks for human–AI collaboration, trust calibration, explainability, and adaptive feedback across patient and clinician journeys.

• Champion whole-human empathy in product design, considering cognitive, emotional, and physical needs across diverse user contexts.

• Embed human factors engineering principles into design and prototyping workflows to satisfyIEC 62366,GxP, and usability validation standards.

Regulatory & Compliance by Design

• Collaborate with RA/QA to ensure all design activities align withSaMD, GMLP, MDR, FDA,GxP, and EU AI Actrequirements.

• Embed regulatory checkpoints, design history file (DHF) generation, and documentation automation directly into design processes and tools.

• Contribute toPredetermined Change Control Plans (PCCPs), risk management files, and post-market surveillance strategies for AI-enabled products.

Platform Integration & Cultural Enablement

• Align design systems, prototyping frameworks, and AI standards with the broader Digital Health Platform strategy.

• Lead workshops, training, and design discovery sessions to promote cross-functional innovation and agile co-creation.

• Drive adoption of intelligent design frameworks across product, content, brand, and engineering teams — enablingconsistent, compliant, and scalable digital health experiences.

Key Skills

• Deepexpertisein AI/ML design, cognitive systems, and intelligent interaction frameworks.

• Proven experience withSaMD development,GxP-regulated medical software, and digital health design controls.

• Strong mastery of human-centered design, human factors, and usability engineering (formative and summative studies).

• Skilled in design systems creation,DesignOps, and process automation forcompliance and scalability.

• Strategic understanding of explainable and ethical AI, including trust, transparency, and clinical integration.

• Exceptional cross-functional leadership; able to influence without direct authority across content, brand, UI, and regulatory teams.

• Excellent communication and facilitation skills for executive, clinical, and technical audiences.

Education, Experience, and Competencies

Required:

• 7+years of experience in digital product design and prototyping, including AI/ML-integrated design.

• Demonstrated success leading design systems and rapid prototyping programs inhealthcare or medical device contexts.

• Fluent in English; strong ability to communicate complex design and AI concepts across domains.

Preferred:

• Advanced degree in Design, Human Factors, Cognitive Science, Biomedical Engineering, or related field.

• Experience with explainable AI, GMLP, IEC 62304, and lifecycle management of intelligentSaMDs.

• Familiarity withEU AI Act,GxPframeworks, and ethical AI principles for clinical-grade software.