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Nextkidney SA(www.nextkidney.com) is a Swiss international operating company developing Medical Devices located in Lausanne, with its head office in The Netherlands and subsidiary in Singapore.We are a fast growing innovative company developing and commercializing world’s first portable hemodialysis device. We do business in Europe, Asia, Middle East and US. You will collaborate with organizations and companies all over the world and be part of an open modern working atmosphere where business and professional human values meet.Our company mission: create a better life for Dialysis patients all over the world!We are looking for a colleague in our R&D Department :Your mission:Key responsibilities and accountabilities :Define and develop system-level test tools to verify product safety and performance.Plan, execute and document development, verification and validation tasks defined in the framework of the research and development projects.Analyze data using scientific tools (e.g., spreadsheet, graphical, statistical).Participate in research & development processes and meeting.Provide information to other teams regarding systems needs and systems outputs, including presentation and meetings.Interact with external supplier or partners.Supervise relevant activities conducted by other parties (technicians, suppliers).Specific responsibilities :Contribution to CE and FDA 510 k submission testing activitiesImprovement of the systemSupervision of external contractors for testing activities (Shelf-life, transport, biocompatibility, integrity of packaging)Supervisionof production testing activitiesKnowledge, skills and abilities :A sound understanding of the physical systems, notably mechanical systems, fluidic systems, and sensors.A good command of statistical tools, e.g., regressions, model fitting, descriptive statistics.Programming skills: ability to use and develop scripts for the acquisition and analysis of data using a scripting language is a plus.Technical English writing skills: ability to write reports following QMS and incorporate results analysis in a concise manner.Good communication skills are required both within and outside the company, with suppliers, contractors, or partners.Autonomous and a team player.Responsible, rigorous, and attentive to details.Education and experience :Engineer or equivalent university degree.Experience with medical devices regulations a plus.Start of the missionAs soon as possible.To applyPlease send you cover letter toWrite an emailalong with your resumé.Important remarksFor this particular position, please note that only candidates possessing a Swiss passport or those fromUE-27/AELEliving in Switzerland and having a permit B will be considered for reasons of long waiting in obtaining work permits for the other candidates. Lire la suite