Global Director Gastroenterology

PENTAX Medical EMEA (Europe, Middle East, Africa); Hamburg; Vor Ort; EUR 70.000 - 90.000; Vollzeit

Zusammenfassung

A specialized medical device firm in Hamburg is seeking a Product Manager to lead the global GI endoscopy portfolio. Responsibilities include portfolio strategy, product development, and financial analysis. Ideal candidates will have 8+ years in medical devices, strong analytical skills, and fluency in English. The role requires strategic leadership and the ability to influence cross-functional teams.

Qualifikationen

• 8+ years in medical devices focused on GI endoscopy or closely related scopes.
• Deep knowledge of GI clinical workflows and market nuances.
• Familiar with FDA 510(k), EU MDR, ISO 13485.

Aufgaben

• Own the global GI endoscopy portfolio and set strategic direction.
• Translate user needs into product requirements.
• Build business cases aligned with company targets for new products.

Kenntnisse

Strategic thinking

Analytical skills

Leadership

Financial acumen

Technical knowledge

Ausbildung

Bachelor’s degree in Engineering, Life Sciences, or Business

Master’s / MBA preferred

Jobbeschreibung

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.