Summary. Own the global GI endoscopy portfolio - from initial insight through profitable retirement. Acting as the product-category CEO, you set portfolio direction, guide product development, make / buy decisions, shape clinical evidence, and lead cross-functional teams worldwide to deliver category-defining flexible reusable endoscopes.
Main Responsibilities / Main Tasks
Portfolio strategy & product road-mapping
* Craft a multi-horizon roadmap with clear scenarios and option-value choices.
* Secure budget and coordinate with Finance to keep the plan funded and visible to leadership.
Product requirements & development leadership
* Translate user needs and market insights into product requirements and design inputs; freeze requirements in partnership with R&D Japan.
* Own timeline and COGS targets; chair Stage-Gate core-team meetings and resolve scope / resource conflicts.
Business case & financial tracking
* Build robust business cases aligned with company targets for new products, design changes, or product enhancements.
* Track COGS and timeline performance versus plan; trigger corrective actions when targets are at risk and report variance to Senior Management.
Clinical claims & evidence generation
* Define product claims and clinical indications for use; partner with Clinical Affairs to create and run benchtop, animal, and clinical validation plans.
* Hand over validated claims to Global Marketing for messaging and launch materials.
KOL engagement for product definition, validation & advisory
* Maintain a targeted global network of GI Key Opinion Leaders (KOLs) who provide early feedback on concepts, prototypes, and real-world testing, ensuring products meet market expectations and launch with advocacy.
* Manage regular advisory meetings to inform the strategy in the GI product category.
Analytics-driven decision-making
* Fuse usage data, complaint & repair trends, market data, and cost analytics to prioritize features, margin fixes, and EOL calls.
Strategic partnering / 3rd-party integration
* Scout external technologies and lead diligence with Business Development to fill roadmap gaps or accelerate time-to-market.
People & cross-functional leadership
* Inspire a matrix of R&D, Clinical, QARA, and Supply-Chain specialists as part of the Product Development team.
Qualifications & Experience
* Bachelor’s degree in Engineering, Life Sciences, or Business (Master’s / MBA preferred).
* 8+ years in medical devices, with a focus on GI endoscopy or closely related flexible scopes; proven success leading global NPIs from concept to launch.
* Deep knowledge of GI clinical workflows (OR & reprocessing) and regional market nuances (US, EU, Japan, China).
* Active network of GI KOLs; comfortable observing live procedures.
* Strong financial and analytical skills (business cases, COGS, pricing, dashboards).
* Familiar with FDA 510(k) / De Novo, EU MDR, ISO 13485 & IEC 60601.
* Experience with make-buy partnerships or integrating 3rd-party products.
* Fluent English; Japanese or another major language a plus.
* Willingness to travel approximately 30% worldwide.
Key skills & capabilities
* Strategic thinker who articulates compelling business cases and influences executive leadership.
* Technical and clinical credibility; able to debate optics, sensor physics, reprocessing chemistries, and digital-imaging trends with engineers to address clinical needs.
* Strong influencer who can drive projects in a matrix organization.
* Evidence-driven decision-maker with concise, audience-specific communication.
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