**Requistion ID** : 78355 Wellspect Healthcare är en ledande global leverantör av innovativ medicinsk utrustning som hjälper människor med blås- eller tarmdysfunktion. Wellspect har fler än 1000 anställda runt om i världen som dagligen bidrar till att göra skillnad för alla de människor som behöver företagets produkter och tjänster. Wellspect är en världsledande tillverkare av intermittenta urinkatetrar, där LoFric® är det mest kända varumärket. Företaget har också utvecklat Navina™, en lösning som hjälper mot kronisk eller allvarlig förstoppning och avföringsläckage. Navina™ är förmodligen marknadens mest avancerade irrigationssystem, en smart digital lösning som kombinerar hög användarvänlighet med klinisk effektivitet. Wellspect strävar efter att bli klimatneutralt med minsta möjliga påverkan på miljön. Företaget har sitt huvudkontor i Mölndal, är verksamt i över 30 länder och är en del av Dentsply Sirona – världens största tillverkare av professionella dentala lösningar. Dentsply Sirona är listat på NASDAQ i USA under symbolen XRAY. Besök www.wellspect.com eller www.dentsplysirona.com för mer information. Join our Production Development team and continue shaping medical device production of tomorrow. As we are continuing to step up the pace in product and production development, we are now looking for a Production Development Engineer to join us at our HQ in Mölndal. Our workplace is characterized by teamspirit and passion, we like challenges and also enjoy a good laughter every now and then. At Wellspect we are proud to have an in-house, highly automated medical device production with interconnected chemical processes, multiple transport systems and packaging machines. We have strict requirements on material traceability and in-line quality control; an area where we apply Big Data principles and develop machine learning. As a Production Development Engineer, you will play a key role in the development and implementation of new and improved production processes as well as ensuring compliance of existing production equipment. Responsibilities: + Lead or participate in equipment investment projects all the way from concept, via risk- and requirements handling, testing and validation to commissioning and handover. + Participate in cross-functional project teams where you will collaborate with both external equipment suppliers and internal stakeholders/departments to find efficient production solutions with Design for Manufacturing as a guiding principle. + Manage and participate hands on in installation, start-up/commissioning, testing/verification activities in our cleanroom production in Mölndal. + Lead or participate in improvement projects both related to ongoing production but also to the ways of working within production development. + Develop documentation in compliance with Wellspect’s quality management system built on regulatory requirements from European medical device and FDA quality systems regulations. + Establish and maintain working relationships with supplier including evaluations and supplier visits. **Who you are?** We think you are a structured problem solver and efficient communicator. You take pride in your engineering solutions and in getting things done. Background / Qualifications: + an academic background, preferably in mechanical/automation/electrical engineering or equivalent with experience from production development + knowledge of automated manufacturing process development; preferably from the food/life science or other regulated industry + some project management experience + experience from working with technical specifications and external equipment suppliers + knowledge of Lean production and Design for Manufacturing principles + experience from qualification/testing/process validation, preferably within life science or other regulated industry + an interest in and understanding of automation technology including Industry 4.0 principles + some experience with data collection and predictive analyzes in a production environment + experience of mechanical design + documentation and communication skills, in English as well as in Swedish Wellspect’s production is in continuous evolvement and there are always new and interesting projects going on. We offer you a place to develop your skills as part of a cross-functional team and the medical devices we manufacture make a real difference in the lives of our users. That’s a reason to go to work! Please note that we will review applications continuously, so be sure to send in your application as soon as possible.