Design Validation Specialist – Ambu A/S – Ballerup

Are you looking for independence in your job and the possibility to have a high influence on the design validation process in a fast-growing, global medical device company? Then Ambu might be your next career move…We offer a challenging position located at our headquarters in Ballerup where you will participate in securing our ongoing dedication to quality products. You will be part of an effective innovation culture with a tradition of fast completion of projects, which means that there is a visible link between your results and Ambu’s growth.Ambu is a global company with ambitious growth targets. Our ability to identify and develop innovative products is essential for continuous growth within our business areas. You will be an extension to a rapidly growing team as we have an ambitious plan to develop 30 new products during the next couple of years. Driving continuous improvements and guide stakeholders As a Design Validation specialist, your main responsibility will be to ensure that our new visualization products fulfill the user needs by planning and executing design validation activities. You will be part of a team that ensures continuously improvements of our processes. Therefore, you will also be involved in collecting inputs from many different stakeholders and together with a group of subject matter experts you will facilitate needed updates of internal procedures and perform training to ensure your colleges follow our processes. Your responsibilities will include: Define or develop models to simulate clinical use of our new products during design validation activities. Take part in defining user needsSupport the planning and execution of formative activities related to design development and validation.Coordinate design validation activities inhouse and at external partnersWrite design validation plans, test protocols and test reportsExecute design validation testsContribute to the continuously improvement of our design Validation procedures Guide stakeholders to follow our processes for design ValidationBe updated on regulatory requirements for design validation of medical devices. Your backgroundThe candidate could have many different educational backgrounds e.g. a degree within healthcare, health science or medical-related engineering. As we are constantly expanding we are looking for talent with different levels of experience and depending on your experience we can offer the position as a junior position or as a senior position with more responsibilities. But you should have minimum a couple of years’ experience within health science, preferably working with medical devices within one or more of the following topics: Design Validation, Usability/Human Factors Engineering, Clinical Studies, Design Control, Requirement Engineering and/or Design Verification.Preferably you have practical experience with tests, studies or experiments involving human subjects and/or healthcare professionals, such as user research, usability studies, experimental tests, clinical studies, etc.We are working in a very collaborative and agile environment, where open and honest discussions are an integral part of the way we solve complex problems. To succeed in the job, you must have a strategic mindset, be proactive and pragmatic. Furthermore, you must hold good communication skills including speaking and writing English at a high level.Ambu – a visionary and international workplace where your efforts matterAmbu is a company that expands rapidly and has ambitious growth targets. We meet these targets through interdisciplinary teamwork between motivated and highly skilled employees. Your contributions and efforts are crucial to our success and by joining us you will get the opportunity to work in an international head office with an informal working environment. We offer a wide range of professional, social, and financial employee benefits along with exciting job challenges and career opportunities contributing to your job satisfaction.

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