Michael Gächter

Project & Product Leader (PMP®, Prosci®) | Medical Devices & Digital Health | Driving Complex Projects from Vision to Success

Solothurn, Solothurn, Switzerland

About

I am passionate about achieving ambitious objectives and solving complex problems with diverse teams. I lead with a structured approach and an agile mindset, creating clarity and momentum for teams and stakeholders alike, delivering impactful results.

Experience

  • Sr. Platform Manager - Connected Medical Devices at Ypsomed AG
    Jun 2024 - Present · 2 yrs 1 mo

    Experience: - Management of product platform, product variant projects, and product care for the SmartPilot and CliniPilot - connected add-on devices to the YpsoMate autoinjector. - FDA cleared connected autoinjector add-on device (injection data capturing for digial therapy management): Project lead for design changes, design verification and validation, and registration of SmartPilot YpsoMate in USA (FDA 510(k), device class 2) and Europe (TÜV SÜD). Ypsomed AG: Leading developer and manufacturer of injection and infusion systems for self-medication of liquid medications

  • Project Manager - Medical Devices at Gerresheimer
    Oct 2018 - May 2024 · 5 yrs 8 mos

    Experience: - Program manager / project lead for the development, industrialization and registration of a life sustaining pump device for continuous intravenous drug delivery (customer project). - Project lead for the development of an innovative on-body pump device platform for the subcutaneous delivery of large molecules drugs / biologics (internal multi-site project). - Project lead for the development and industrialization of a pump device for subcutaneous drug delivery to improve outcomes and reduce costs in the treatment of heart failure (customer project). FDA clearance and commercialization of drug-device combination product in 2026. - Project planner and manager for a medtech project with Sanofi and Verily Life Science (Google) to develop, industrialize and register a connected pump device, designed to automatically ensure the supply of insulin throughout the day (program stopped due to change in Sanofi's corporate strategy). Gerresheimer AG / Sensile Medical AG: One-Stop-Shop for innovative medical device platform solutions from concept to delivery of the final product

  • Internship - Project Management in IT at Galexis AG
    Mar 2018 - Aug 2018 · 6 mos

    Experience: - Master thesis: "Development and Validation of a Processing Methodology for Interorganisational SCM 4.0 Projects for the Digital Connection of Pharmaceutical Companies" - Methodical accompaniment of an interorganisational project for designing and implementing an IT interface between pharmaceutical companies. Galenica Group: - Galexis AG: Leading wholesaler and service provider in the Swiss healthcare market - Alloga AG: Leading pharmaceutical pre-wholesaler in Switzerland, makes an important contribution to nationwide supply of medicines

  • Internship - Project Management in SCM at InterLog Management GmbH - Beratung für Logistik, Strategie- & Prozesse, Projektmanagement
    Oct 2017 - Jan 2018 · 4 mos

    Experience: - Assistance in operational technical project management in the field of SCM and logistics - Collaboration for a study project at the Institute for Business Engineering at FHNW InterLog Management AG: Corporate consultancy and project management in SCM and logistics with offices in Germany and Switzerland

  • World Trip by Bicycle at Travelling
    Feb 2016 - Jan 2017 · 1 yr

    Southeast Asia, South America and South Africa