It's a good feeling to know you're doing your best with purpose every day. At Artivion, we manufacture high-quality products and solutions for the treatment of aortic diseases. Together with surgeons worldwide, we save lives. In doing so, we rely on the strengths of each and every employee. Your strength counts, too: As an important link in the chain, you make a contribution to saving lives together with us. Contribute your strengths and let us grow together.We are hiring aDesign Quality Engineer II m/f/dYour strength:Minimum of a Bachelor’s Degree in an engineering or science field, or equivalent work experienceSeveral years of hands-on experience; preferably in an FDA / MDR regulatory industry (i.e., pharmaceutical, biomedical, medical device field) with an in-depth knowledge of current good manufacturing practices, quality system regulations, and ISO standardsSpecific experience in medical device design controls for developing and preparing design specifications and effectively demonstrating that the design output fulfills the design inputSpecific experience designing, preparing, executing, and statistically analyzing validations as well as developing report packages to approve equipment, processes, methods and softwareGoal-oriented team player with an open mind and a high level of adaptability, eager to embrace new ideas quicklyAbility to work independently with minimal supervisionYour contribution:Partner with R&D and other cross-functional groups to support the successful development and commercial launch of new productsPartner with R&D and other cross-functional groups to support the proper application of design controls, process validation, risk management, and the investigation / correction of design failures / challengesReview and approve design input requirements as appropriateReview and approve the translation of design input requirements into design output documentsEstablish and/or maintain risk management files to support product lines and corporate projectsReview and approve design verification / validation protocols and reports that demonstrate the design output fulfills the design input requirementsReview, approve, and validate test methodsConduct investigations, documentation, review, and approval of non-conformances, CAPAs and customer complaints as necessaryOur strength:An exciting field of activityAn autonomous area of responsibilityActive participation in an international quality teamIntensive training with mentoring programDiverse benefits such as hybrid working, business bike, company pension and subsidy for our canteenApply now and join the Artivion team. We look forward to hearing from you!Apply now!Maximiljane Tyrs, T: 07471 922 352 JOTEC GmbH, a wholly owned subsidiary of Artivion, Inc. Lotzenäcker 23, 72379 Hechingen, www.artivion.com