Design Control Specialist

Atos At Atos Medical, we are passionate about making life easier for people living with a neck stoma, by providing personalized care and innovative solutions. We now have an open position in our R&D department as a design control specialist to support development of new and innovative devices. About the role In this position you will be a member of our R&D team located in Hörby Sweden. We are a highly engaged team that works in cross functional innovation project teams to develop the best medical devices within laryngectomy to make life easier for our users. We are now looking for a specialist that can support us with expertise to a structured medical device product development process. Our key objective is to develop the best innovative products that support the users’ needs through coherent and meaningful design control, risk management and usability engineering processes and documentation. More specifically you will: * Be an active player in a cross functional product development team where you will be responsible for the design control and design review process. * Support the creation of design and development documentation to support the technical file. * Responsible for the product risk management process and file incl facilitation of product risk workshops and product risk management reviews with a cross functional product development team. * Participate in the usability engineering process and create documentation for the usability engineering file. * The role is based at our site in Hörby and we apply a hybrid working model, and you are expected to work 3 days on-site. About you You are a true team player with a positive and flexible mindset, who understands how to reach joint goals and enjoy working with multiple tasks at the same time. You have a proactive mind-set and a constructive attitude to drive results combined with the ability to plan, execute, and meet deadlines. You have a degree in engineering, pharmaceutics, life science or similar and preferably, you have 5+ years of experience with some of below points: * Design control activities such as requirement engineering, design verification and facilitating design reviews * Understanding or experience with risk management and usability engineering. * Working in a cross functional product development team. * Regulations, standards and guidelines within the medical device area e.g. MDR, ISO 13485, ISO 14971 or FDA 21 CFR 820.30 We have identified the personal competencies for this role, that we believe will be a key to your success. Do you recognize yourself in the following? * Working with people - You are a true team player with a positive and flexible mindset, who understands how to reach joint goals through compromise. * Analysing - You have a holistic view. You enjoy working with multiple tasks and consolidate the piece of the puzzle to create a full picture. * Planning & organizing - You find it natural to plan and execute your work individually as well as with the team. * Delivering results & meeting customer expectations - You have a proactive mind-set and a constructive attitude to drive results and meet deadlines and you are not afraid to take on new challenges. As you join us, we will make sure to support you, and you will have every chance to develop your expertise in R&D. Does this sound like the perfect challenge for you? Please send your application today. Last date of application is 25th of June, but applications will be reviewed on an ongoing basis. If any questions, feel free to reach out to hiring manager, Rikke Gleerup Ovesen, via email:  [email protected]