Engineering consultant, Medical and laboratory equipment (FASTLab 1- FASTLab 2) PET Radiochemistry System (medical devices class I), Root cause analyses and redesign of technical components (ISO 13485), manufacturing and design engineering. High Volume engineering and CAD mold engineering. Change Control Order participation and Technical Reguirements documentation.
Interim product management and engineering, implementing Quick Connector for Mistral Air blower device (Medical device Class I). Validation process for marking UL. Implementing of process changes in QMS and Risk Management (FMEA) comply to ISO 13485.
Phillips Medisize Selfilling Cartridge
Healthcare product development (Self Filling Insulin Cartridge), Redesign process according to ISO 13485, Root cause analyses, FMEA, injection molded plastic part design, mechanical component and assembly design. Create and execute test plan within medical standards (medical devices class IIa).
Product development Healthcare/ Medical devices (including Wound drainage pump and ENT workunit), (medical devices class I-II), Product design and supervision of engineering process. Project coordination design projects.
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