Hi, I'm Sebastian Penhouet!

CTO & Site Manager at AIRAmed

About

CTO and Site Manager in MedTech. Since 2020 I have taken an AI medical device for brain MRI analysis from an early prototype to FDA 510(k) clearance and MDR certification, and built the R&D team up to 22 people. Today I run development with a lean team that relies heavily on LLM agents, and I still work on code and architecture myself.

In my free time I build open-source tools around documentation, developer workflows and AI agents.

Work Experience

Aug. 2026 - Present

Site Manager

AIRAmed GmbH

Germany, Tübingen

  • Site responsibility in addition to the CTO role
  • Budget, purchasing, contracts, HR decisions and staffing, company roadmap and facilities
  • Management Representative for the QMS (ISO 13485) and primary contact for authorities and notified bodies
June 2025 - Present

Chief Technology Officer (CTO)

AIRAmed GmbH

Germany, Tübingen

  • Responsible for technology, product development and AI for an FDA-cleared, MDR-certified AI medical device for brain MRI analysis
  • Run development with a lean team, with development and QM processes rebuilt around LLM agents
  • Redefined the medical device boundary to shrink the QM-relevant scope and speed up work on non-device components
  • Made the product agent-ready and moved technical documentation and the QMS to Markdown/Git
Jan. 2020 - May 2025

Head of Research & Development

AIRAmed GmbH

Germany, Tübingen

  • Took an early prototype to a market-ready AI medical device: FDA 510(k) clearance (2023) and MDR certification (2024)
  • Built and led R&D up to 22 people across data science, backend, web, project management and support
  • Designed a GDPR-compliant cloud platform with DICOM integration into hospital IT and on-demand GPU compute
  • Defined the AI/ML strategy and developed deep learning models for segmentation, volumetry and longitudinal analysis
Oct. 2016 - Dec. 2019

Working Student

itdesign GmbH

Germany, Tübingen

Oct. 2013 - Sept. 2016

Co-Op Student

itdesign GmbH

Germany, Tübingen

Education

2016 - 2019

MSc. in Computer Science

University of Tübingen

Germany, Tübingen

2013 - 2016

BSc. in Computer Science

Baden-Wuerttemberg Cooperative State University (DHBW) - Stuttgart Campus Horb

Germany, Horb am Neckar