Johan Custers Email & Phone Number

Eindhoven, North Brabant, Netherlands

Eindhoven Area, Netherlands

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

Eindhoven Area, Netherlands

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.

Phd, Physical Chemistry

Thesis: Thermo-reversible binding of multivalent ions by surfactant self-assembly A aqueous micellar system was designed and described.

Bsc, Physics, Physical Sciences

Msc, Organic Process Development, Organic Chemistry, Chemical Engineering

Thesis: - Scale-up and optimization of the synthesis of (S)-propane-1,2 diol - Scale-up of 3,4,5-Tri-dodecyloxybenzoic acid Overall.

Education record

Education record