(Senior) Industrialisation Engineer

Vor 6 Tagen


Munich, Deutschland PULSION Medical Systems SE Vollzeit

With a passion for life Join our diverse teams of passionate people and a career that allows you to develop both personally and professionally. At Getinge we exist to make life-saving technology accessible for more people. To make a true difference for our customers – and to save more lives, we need team players, forward thinkers, and game changers. Are you looking for an inspiring career? You just found it. We are currently looking for an experienced (Senior) Industrialisation Engineer (m/f/d) Disposables to join our R&D department in Feldkirchen, Germany. As part of our Product Area Critical Care with special focus on the development of sterile disposables we are looking for a knowledgeable and self-driven Industrialisation Engineer who supports us in bringing our product ideas to life. We at Getinge believe in self-organized and cross-functional teams, adopting lean and agile methods in product development and project management to successfully realize medical technology in a fast changing and complex environment. We closely collaborate with other international Getinge sites e.g. in Solna, Sweden and Antalya, Turkey within our business area Acute Care Therapies, for development and manufacturing. Also, daily cooperation with our contract manufacturing partners is key. Tasks & Responsibilities: Participates in the product design & design change process to ensure manufacturability (DfMAT) of new/changed products to be introduced in context of New Product Introduction and Product Care Supports material selections considering all applicable aspects including a strong focus manufacturability Designs production processes with our external partners and perform technical risk assessment of these using methods like pFMEA Is accountable for process and Manufacturing Requirements based on Product Specifications and Test Requirements from R&D Coordinates purchase and installation of related equipment and tools, according to these requirements and in collaboration with our manufacturing partners Proofs suitability of the selected processes and equipment for production of sterile disposables by means of equipment, test method and process validation Coordinates pilot runs to release processes and equipment for production start and provide support during ramp-up until hand-over to regular production Supports process audits at suppliers and contract manufacturers Investigates and resolves technical problems involving product performance and production processes and equipment Apply lean manufacturing principles Desired Profile: University degree (Bachelor, Master, Diploma) in Industrial/Production Engineering, Polymer Engineering, Mechanical Engineering or related fields Minimum of 5 years hands-on engineering experience in the medical device industry Fluency in English (written and spoken) and basic German language skills (willingness to advance) Proficiency in lean and agile development environments (e.g. Scrum, Kanban) and self-organized teams  Experience in design transfer and manufacturing transfer projects Proficient in working with statistical tools like Minitab Strong knowledge of polymer manufacturing technologies (part molding, overmolding, multi-lumen tube extrusion, balloon blow molding), assembly techniques (cutting, tipping, skiving, braiding, bonding) and downstream processes (packaging, sterilization) Familiarity with FMEA, 8D, SPC, A3, and Lean Manufacturing Experienced with process (pMap, pFMEA, IQ, OQ, PQ) and test method validation, as well as with statistical sample planning and statistical analysis of measurements A continuous improvement mindset with a result and quality-driven approach Cross-cultural intelligence On-site work for at least 2 days per week is expected. Hence, residing in the greater metropolitan area of Munich is advantageous. We offer: High quality products in a life-saving environment Attractive conditions, 30 paid vacation days per year Possibility of mobile working and workation within the EU Modern workplace equipment Business Bike, e-gym Wellpass, and corporate benefits Career opportunities in a well-known company Individual trainings  About us With a firm belief that every person and community should have access to the best possible care, Getinge provides hospitals and life science institutions with products and solutions aiming to improve clinical results and optimize workflows. The offering includes products and solutions for intensive care, cardiovascular procedures, operating rooms, sterile reprocessing and life science. Getinge employs over 12,000 people worldwide and the products are sold in more than 135 countries.



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