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:
- Szilvia Endrenyi, CEO and experienced founder in Medical Devices. 

- Dr. Federico Soria, CSO: KOL in ureteral stents and inventor of the technology.

Location:
Europe, ideally Madrid or Barcelona. Hybrid/remote, with regular travel to manufacturing and testing partners.

What you'll do

Manufacturing & quality

• 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.
• Flexible 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.