Led cross-functional, international teams across Germany, USA, India, and Czech Republic to develop Class IIb medical devices in compliance with ISO and EU MDR standards. Project 1: Development of a Reusable Insulin Pen Injector ▪ Acted as primary point of contact for a Germany-based customer, ensuring effective communication and project alignment. ▪ Organized and maintained complete Design History File (DHF) and Device Master Record (DMR) documentation. ▪ Managed the end-to-end development of a reusable pen injector for insulin, and OversawTest Methode validation and testing as per ISO 11608 standards. UDI marking development for both the device and its packaging. Qualification of a manual assembly line, including IQ/OQ/PQ validation activities. Human Factors Engineering studies, including both formative and summative evaluations. Project Budget and invoicing. Project 2: Disposable Combination Product (Teriparatide & Methotrexate) ▪ Collaborated with a Greek pharmaceutical partner on the development of a disposable combination product. ▪ Supported the design and implementation of an automated assembly line in close coordination with customer engineering teams. ▪ Contributed to verification and validation planning, project currently in the testing and verification phase.