Ninke Bourgonjon Email & Phone Number

Amsterdam, Nh, Nl

Amersfoort, Netherlands

Meeting regulatory requirements, reducing risk and optimizing usability.Please visit Garza MD's website: https://garza.nu/

Utrecht, Netherlands

Utrecht, Netherlands

Utrecht, Netherlands

Tolbert

Utrecht Area, Netherlands

Leusden, Netherlands

As Quality Assurance Manager at Cablon I'm responsible for overall development, implementation, and maintenance of the Quality Management System.Ensuring that our products (software and hardware for radiotherapy, radiology and pharmacy) and services are of high quality and meet both external and internal requirements. This includes legal compliance and customer expectations.Medical Devices Directive / Medical Device Regulation , IEC 13485, IEC 14971, IEC 62366, IEC 62304, IEC 60601-1, ISO 9001

Leusden

As Quality Assurance Manager at Diasoft I'm responsible for overall development, implementation, and maintenance of the Quality Management System.Ensuring that our products (software and hardware for kidney dialysis treatment) and services are of high quality and meet both external and internal requirements. This includes legal compliance and customer expectations.Medical Devices Directive / Medical Device Regulation , IEC 13485, IEC 14971, IEC 62366, IEC 62304, IEC 60601-1, ISO 9001

Leusden, Netherlands

Diasoft, Leusden, Manufacturer of software and hardware for kidney dialysis treatment2015 – now: Team Leader Design, Development (D&D) and Documentation Responsible for monitoring project progress, verification, validation and release. Enormous progress was made in the number of projects that have been successfully released.Development of a well-defined process for requirements gathering, risk analysis, usability and project documentation. The quality and user satisfaction of our products is increased, measured by customer feedback through our feature request system and surveys. Training of new team members in our Quality Management System.2011 – 2015: Team Leader Documentation, Project Leader D&D Set up a system for control of user documentation and translations. Traceability of all document changes is now guaranteed. Ongoing improvement of our quality management system to continually conform to the latest European quality standards. Design of a new hardware interface for data connectivity, including CE marking.2007 – 2011: Team Leader Documentation and Designer Engineer Design of a hardware interface for data connectivity in dialysis treatment from first customer requirements to production. The product includes electronical hardware, software, and mechanical parts. Responsible for the process, communication with stakeholders and the end result. Designer of the mechanical parts. Implementation of the production and logistics of the product.CE marking of the products (medical device class IIb). Responsible for setting up several procedures in our quality management system conform ISO 13485.

Nederland

As a freelancer I worked in turns for these three clients:Diasoft, Leusden (Manufacturer of software and hardware for kidney dialysis treatment)Dok Medical Design, Amsterdam (Product Design Agency)Brandes en Meurs, Utrecht (Product Design Agency) Detailed design of medical devices. Detailed design of professional consumer products. Writing, editing and publishing of a user manual for kidney dialysis management software.

Amsterdam, Netherlands

Device design and component design of medical devices, released to the market in small series.Detailed design and engineering documentation for (parts of) an endoscope reprocessor, thoracic scanner, bucky table and a wheelchair.Advice on CE marking.

Utrecht, Netherlands

Department Physics of the human beingResearch into the control of arm movements of men, the estimation and correction of arm movements in an unexpected or unknown force field.Teaching Physics of the human being to Biology students.

Linschoten, Netherlands

Designer of a patient lift for patients up to 300 kg, from first ideas to realistic prototype.

Master Of Science (M.Sc.), Industrial And Product Design

Activities and Societies: C.S.R.-Delft Graduation project Design of a hand exercise device for Post-traumatic dystrophy patients, final.

Vwo, High School/Secondary Diplomas And Certificates

Activities and Societies: School orchestra Maths Physics Biology Chemistry Dutch English French Latin