Burgdorf, Berne, Switzerland
I bring together science, medical affairs, human factors, clinical evidence, and systems engineering to support evidence-based innovation in combination products and medical devices. At Ypsomed, I lead the Science, Medical Affairs, and Human Factors Teams across drug delivery and digital health device platforms. My work focuses on translating product strategy into evidence-generation plans, clinical and usability studies, scientific publications, and clinically meaningful product innovation. Before moving into science and medical affairs leadership, I held systems engineering roles at Ypsomed, Abbott, and BIOTRONIK, supporting complex medical device platforms in drug delivery, cardiac support, cardiac rhythm management, digital health, and connected device ecosystems. My background combines an engineering doctorate, clinical research experience, R&D leadership, human factors validation, clinical evaluation, and peer-reviewed scientific publications. I have planned and conducted patient studies, led cross-functional engineering and scientific teams, managed external partners including CROs and study sites, and contributed to international standardization through ISO/TC 194/WG 4 on clinical investigation and evaluation of medical devices in humans. I am particularly interested in evidence-based medical device innovation, user-centered product development, clinical evaluation, human factors engineering, and the translation of technical concepts into safe, effective, and meaningful healthcare solutions.
- Lead three functions: Medical Affairs, Usability / Human Factors, and Science. - Define and align scientific strategy with Marketing, R&D, and Innovation across drug delivery and digital health device platforms. - Oversee usability and clinical studies, coordinating internal teams and external partners including individual contractors, study sites, and CROs. - Manage the science budget, resource planning, priorities, and external collaborations. - Drive scientific publication strategy for peer-reviewed journals, congresses, and conferences. - Serve as process owner for Clinical Evaluation, Clinical Investigation, and Validation. - Supported device platforms: YpsoDose, SmartPilot, CliniPilot, Autoinjectors, and (Prefilled) Pens. - Member of ISO/TC 194/WG 4, “Clinical investigation and evaluation of medical devices in humans.”
- Managed staff planning and professional development systems engineers and architects. - Led systems engineering best practices and acted as process owner for systems engineering. - Supported product development across YpsoDose, YpsoPod insulin patch pump, SmartPilot, CliniPilot, and Smart Pen. - Connected systems engineering processes with product architecture, requirements management, and cross-functional development needs.
- Led systems engineering activities for the core product developments CentriMag Next and HeartMate Next. - Provided technical leadership for two systems engineering teams across complex medical device development programs. - Supported cross-functional alignment between product requirements, system architecture, development strategy, and technical execution.
- Feature lead for tachycardia detection algorithm specifications for Rivacor / Acticor. - Analyzed real-world and clinical data to support product performance evaluation and innovation management. - Led the strategic global rollout of requirements management software. - Supported systems engineering, requirements management, and feature development for cardiac rhythm management technologies.
- Worked in R&D Systems Engineering for cardiac rhythm management devices. - Supported early systems engineering activities across requirements, specifications, and cross-functional product development.
- Led electropathology research activities focused on FEM simulations of pathological currents in the human body. - Developed computational models to assess current distribution and dosimetry in medically relevant exposure scenarios.
- Planned and conducted in vivo patient studies on electromagnetic interference in patients with cardiac implantable electronic devices. - Generated clinical and scientific evidence on the interaction between everyday electric and magnetic fields and cardiac implantable electronic devices. - Published first-author and co-authored research in cardiology, electrophysiology, and biomedical engineering journals, including high-impact clinical publications.