Germany
Production Process Development & Engineering
Medtech · Biotech · Lifescience · Consumables: product lifecycle management, change control · Product development, design validation, V&V, usability, design controls · Packaging · Process development, process validation IQ/OQ/PQ · Biological safety, sterilisation, bioburden, extractables, leechables · Industrialisation, industrial engineering · Plastics technology, injection molding, bonding · Assembly, assembly automation · Medical Devices, Clinical Consumables, Disposables · 13485/MDR/FDA
Manufacturing of Medical Devices Team lead Industrialisation, NPI, Lifecycle and Operations Engineering: - precision injection molding process development & validation IQ/OQ/PQ, Stasa DoE (POM, PBT, PC, PC/ABS, ABS, PP), - mold making & DFM/DFA (prototype and low-cavity =<8 cav.) - injection molds specification and sourcing (4 - 16 cav., hot runner, pressure sensors) - injection equipment sourcing (IMM, peripherals, central feeding) - decoration process development & validation (laser marking and pad printing) - automated and manual assembly equipment sourcing & process validation (<2 million pcs/yr) - methods (ERP, MES, layouts, process flow, system docs.) - NPI project management - implementation of Group standards and good practices in the greenfield plant Team lead of Engineering incorporating: - injection eng. dept. - assembly automation eng. dept. - methods eng. dept. - industrialisation project management team - injection equipment team - mold design and tooling shop Non-sterile medical devices - drug delivery pen injectors, class IIb, ISO 13485, EU MDR.
Manufacturing of Medical Devices. Industrialisation Project Management. Injection molded components, assembly, coating, laser marking on plastic parts. Sterile consumables for ophthalmology - pre-loaded intraocular lense (IOL) implants delivery injectors, class III, ISO 13485, EUMDR, FDA.
ESG, Circular Economy, sustainable & renewable energy. Manufacturing and re-processing. Supporting holding's subsidiaries (start-ups) within engineering and industrialisation activities. Circular Carbon GmbH (Hamburg) https://circular-carbon.com Autarq GmbH (Prenzlau) https://www.autarq.com Flaxres GmbH (Dresden) https://www.flaxres.com
Development of photovoltaic roof tiles. Development of components and technology. Fully automated manufacturing process. Commissioning of robotised PV-tiles assembly line to the end user: Skarpness AS, NO.