ViCentra works on the design and making of the Kaleido: a compact, simple and user friendly insulin pump.

As a Mechanical Design Consultant and later as a Consultant Project Engineer, I worked on several projects and supported with multiple activities to get the Kaleido back to the market.

• I improved the design of multiple injection-molded product components (DFA, DFM) and worked together with a mold maker supplier in the design, production and validation of the molds.
• I worked together with the Manufacturing Engineers on the cleanroom production machines to improve machine and product quality, reduce maintenance and to ensure production tooling was ready for mass production.
• I supported the R&D team with Design Verification tooling design, protocols, execution of the testing activities and reporting.
• I worked together with a manufacturing and electrical engineer to CE mark the machines (gap assessment, risk assessment, CE documentation, machine safety design, regulations, technical documentation)
• I worked together with a machine builder to duplicate the machine line and was partly responsible for validation of the machines (IQ, TMV, PC, OQ and PQ).

Mechanical aspects of product design, test tooling and production tooling. CE marking machines. 

• Design specifications and wishes
• Idea & concept generation
• Prototyping
• Fine mechanic design with optimal price/performance ratio
• Design for mass production (DFA/DFM)
• Work according medical quality procedures
• Testing
• Manufacturing Engineering
• Construction
• Machine building
• Collaboration