Zurich, Zurich, Switzerland
Biomedical Engineer working as a Medical Device Software Engineer and Technical Project Lead in the diagnostics and laboratory automation space. I currently work on bringing research software and lab workflows into validated medical device products, coordinating development across software, QA/RA, and laboratory teams. My focus is on transforming complex, regulated requirements into reliable and usable solutions. I enjoy roles where technical depth and leadership overlap, such as aligning people, processes, and technology, keeping projects moving, and ensuring quality and compliance are built in from the start. Most of my current work sits around medical device and research software development, lab automation, system integration, and regulated product development.
- First technical employee of Navignostics and founding lead for medical device software development, shaping the company’s software strategy, architecture, and development processes from an early-stage research environment to regulated diagnostic products. - Leading end-to-end medical device software development for tumor sample analysis, translating image analysis and machine learning approaches into regulatory-approved diagnostic solutions. - Owning the complete software lifecycle and computerized system validation, including architecture decisions, release planning, risk management, and QMS documentation, ensuring compliance with EU IVDR, FDA, ISO 13485, and IEC 62304. - Building and managing the software platform and infrastructure, including cloud computing, computational resources, CI/CD pipelines, cybersecurity, and scalable environments for medical research and clinical use. - Acting as the technical reference point, working closely with the C-suite, regulatory, manufacturing, and product teams on software, automation, and infrastructure decisions. - Driving clinical and laboratory software development, including LIMS integrations and clinical portals, while managing external vendors and ensuring performance, security, and regulatory alignment.
- Applied computer vision and object detection algorithms to identify prosthetic socket reference points. - Developed an augmented reality application to support and improve the prosthetic alignment process.
- Supported pacemaker control and management activities in the Cardiology Department and Coronary Care Unit. - Assisted with clinical workflows in hemodynamics and electrophysiology units.