Ventinova Medical develops and markets innovative medical devices in the field of mechanical ventilation and airway management. Ventinova governs all activities regarding sales, marketing, clinical, QA and RA in-house as well as the system development and software engineering activities with respect to product development. R&D activities involving electronics, mechanics and industrial design are typically outsourced.As the technical lead of all R&D projects of Ventinova my primary focus is the release and development of new products as well as the improvement of the existing product portfolio. Main responsibilities are:- the execution of system level development activities for both active and non-active medical devices.- implementing optimal product solutions in collaboration with the internal development team and external partners/suppliers. - management of projects related to product changes, both in software and hardware.- fulfilled the (agile) product owner role for internal software development team and hardware team (outsourced) by aligning and advising all stakeholders.- maintaining and optimizing all R&D processes and procedures at Ventinova Medical in order to gain efficiency, high product quality and to meet the demands of actual medical device regulations while taking into account a lean principle approach. - constructing / maintaining technical files (DHF/DMR) in scope of MDD/MDR and FDA. - closely involved in activities related to determining product roadmaps and development strategies.- risk management of whole product portfolio- member of Change Control Board (CCB) and complaint teamAt Ventinova I work in close collaboration with Quality, Regulatory Affairs, Operations, Supply Chain and Clinical Validation departments, which has gained me good experience in these areas. I gained a profound knowledge of many relevant international standards, a.o. ISO13485, ISO14971, IEC62366, IEC60601-1, IEC62304, ISO20417 and ISO80601-2-12

As a project leader I was responsible for the R&D strategy and technical coordination of the R&D projects at Afira. All projects are multidisciplinary cooperations with scientific and industrial partners in the Netherlands and abroad.