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Open nowFirst seen 5 hours ago

CTO BraidStent (The Collider Programme)

Mobile World Capital5 open roles

Where
Madrid, Spain
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Your applicationOpen nowCTO BraidStent (The Collider Programme)Mobile World Capital · Madrid, Spain

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  6. 44.6%60 days
This job: first seen 5 hours ago

The posting

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.
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