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 and CEO.

What we're looking for ~ Degree in biomedical engineering, materials science, polymer or mechanical engineering, or related field. ~3+ years hands‐on in Class IIb/III medical device development and manufacturing. Implantable or minimally invasive devices a plus. ~ Proven experience implementing an ISO 13485 QMS and preparing MDR technical documentation (Annex II/III) through Notified Body review. ~ Working knowledge of ISO 14971 risk management and design-control principles. ~ FDA experience (510(k), De Novo or PMA) is a strong plus. ~ Comfortable in a startup environment; fluent in Spanish and English.

What we offer Founding team membership with equity, milestone-based vesting. The chance to lead technical development of a first-in-class device from spin-off to CE Mark. Base salary from company incorporation, in line with experience. Versátil working hours; open to part-time or phased incorporation, especially during the pre- and early post-constitution period. A collaborative deep-tech ecosystem, with clinicians, researchers, and incubator/accelerator partners.

📌 Head Of Packaging Technology (Madrid)
🏢 FORESEE
📍 Madrid