CTO BraidStent (Madrid)

CTO BraidStent (Madrid)

04 oct
|
FORESEE
|
Madrid

04 oct

FORESEE

Madrid

Madrid, Spain Call4Entrepreneurs - The Collider About the job CTO BraidStent (The Collider Programme) CTO — BraidStent Lead the technical build of a first-in-class medical device, from spin-off to CE Mark. BraidStent is a biodegradable ureteral stent developed at IRYCIS (Instituto Ramón y Cajal, Madrid), one of Spain's leading biomedical research institutes, under the scientific leadership of Dr. Federico Soria. Backed by over a decade of research and a strong publication record, the technology addresses a well-documented unmet need in one of the most common urological procedures worldwide.Currently, the project is part of The Collider's Venture Building programme, with spin-off incorporation planned for late 2026. We're looking for a hands‑on CTO to join the founding team and take the technology from validated science to a scalable, regulatory-compliant product. Current founding team: - Location: Europe, ideally Madrid or Barcelona. Hybrid/remote, with regular travel to manufacturing and testing partners. What you'll do * Define and run the manufacturing process for components,



assembly, sterilisation and packaging, with contract manufacturers and suppliers, under ISO 13485 and MDR. * Own quality: raw material specs, incoming QC, supplier qualification, release criteria, traceability and batch records. Testing & regulatory * Lead pre-clinical validation (bench, in-vitro, in-vivo) with the CSO, and maintain the device specification linking design inputs, risk controls and V&V.; * Build and maintain the ISO 13485 QMS and the MDR technical file (design history, ISO 14971 risk management, V&V; evidence); support Notified Body interactions and the CE Mark submission. * Contribute to early US regulatory strategy (510(k)/De Novo) for future expansion. Team & partners * Select and manage CMOs, test labs and other technical providers. * Translate research outputs and clinical feedback into regulatory-grade documentation and design improvements, working closely with the CSO an

📌 CTO BraidStent (Madrid)
🏢 FORESEE
📍 Madrid

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