Stefan Schwarzbach

WORK HISTORY

EDUCATION

SKILLS

ABOUT STEFAN SCHWARZBACH

A senior development manager and engineer in medical device product development, with the goal of developing innovative products to improve the quality of life of patients.Many years of experience in management medical device projects, as well as my specialist knowledge in software and electronics development help me to positively influence the direction of development projects for medical devices. I support the development of new medical devices from innovation to marketing and I understand how to convert ideas into practicable product solutions and then validate them for their intended use.I create long-term shareholder value for my customers by supporting development departments in completing new products with a high level of quality in compliance with the budget.I combine in-depth analytical skills and a deep understanding of complex systems consisting of the mechanics, hardware, firmware and software. A special focus is on the usability, safety and effectiveness of the active medical systems including active implants.Areas of expertise:+ Development of firmware, software and electronics under ISO 13485, ISO 14971, IEC 60601-1 and IEC 62304+ Design of connected medical devices, including technical documentation and V&V activities+ Knowledge of regulatory requirements for CE and FDA approval+ Building up and management of engineering teams+ Project Management and Product leadership+ Communicator between different departments of companies, including suppliers and other stakeholders