R&D & Process Engineer — Standard Devices

R&D & Process Engineer — Standard Devices PARIS, FRANCE ENGINEERING HYBRID The Materialise medical device portfolio comprises a broad range of solutions intended for craniomaxillofacial surgery, which all can be categorized into Standard and Personalized medical devices. The Research, Development, and Process Engineer will conduct research and development activities for our Standard products and implement process changes (including design transfer activities) to contribute towards consolidating and expanding our Standard device portfolio. R&D and process activities on personalized (3D-printed) medical devices are out-of-scope for this position.Handle clinical and technical discussions with surgeonsGather surgeons' input and identify market and user needsTranslate user needs into technical requirementsScientific and technological watchAssess the technical feasibility of new productsDevelopment activitiesDesign new medical devices and improve existing devicesDefine and execute verification and validation activitiesCreate, review, and maintain technical documentation (DHF and Technical File)Design transfer to relevant teams across the companyHandle technical communication with subcontractorsProcess engineering activities:Build hands-on expertise on the product and process level:Standard manufacturing methodsPost-processing activitiesQuality inspection technologiesIdentify, define, and implement required process changes, including new process validations (for both internal and outsourced processes) and process flow optimizations to increase efficiencySet up processes from scratch for new product introductionsTranslate those changes into operational success by providing the right process documentation (work instructions), training, and supportYour profileMust-have: Strong competencies in product design (including functional dimensioning, CAD, technical drawings, and numerical simulation tools), product industrialization, and standard production processes (such as milling, forging, and laser cutting), ideally related to medical bone screws and instrumentsMust-have: initial experience in the development of a standard product design portfolio with a strong technical focusProficiency in spoken and written English is required, particularly when it comes to technical documentationCan communicate easily with team members, partners, surgeons, and subcontractors, and must be able to adaptPlan, execute, and work with minimal supervision and independent judgmentOut-of-the-box thinking mentality is very importantExperience managing project documentation according to the design control process within medical device DHF is preferred.Knowledge of medical device regulation and quality management systems (ISO 13485) is preferredLocation and type of contractParis, FranceHybridFull-timeShare on:Materialise is a dynamic, international high-tech company, founded in 1990 and headquartered in Belgium, with over 2,300 employees worldwide. Materialise’s mission is to innovate for a better and healthier world through its software and hardware infrastructure and in-depth knowledge of additive manufacturing (also known as 3D printing). Our customers are in diverse industries, such as automotive, aerospace, medical, research, and academia.As a growing company, Materialise is always looking for enthusiastic professionals who want to work in an environment full of revolutionary technology and surrounded by people passionate about their work.When creating a better and healthier world, a good place to start is with yourself. That's why we encourage our employees to prioritize their overall well-being, fostering physical fitness, mental resilience, and social connections through a range of workshops, sports activities, and other events and initiatives that contribute to a balanced and fulfilling work-life harmony.Curious to learn more about this position?Reach out to our team to get the answers to your questions. #J-18808-Ljbffr