Company DescriptionHeadquartered in the U.S., our client is a division of a global company devoted to the research and development, manufacturing, and distribution of highly specialized products for Healthcare and Life Sciences worldwide.This is a great step for someone who is looking to take a seat in a senior role and is looking to further progress down the line. If you are looking to take on a challenging role within a rapidly growing division that provides an A environment and excellent benefits, do not miss out on a potential opportunity to get your foot in the door. Job DescriptionDesign, evaluate, implement and monitor processes and operating systems for the manufacture aortic stent graftsDevelop and implement new mfg processes, execute process validations such as IQ, OQ, PQ protocols and reportsLead the design transfer phase including product development, validation planning, design for manufacturability and assembly, Design of Experiments, process capability analysis, etc.Conduct risk analysis including DFMEA, PFMEA and create/maintain necessary documentation. Support the conversion of small-scale processes into commercially viable large-scale operations. Monitor and improve the efficiency, output and safety of manufacturing processes through observations and measurements as well as by collecting and interpreting data from other technical and operating personnel. Other various responsibilities and projects, as necessary Qualifications4 - year engineering degree or equivalent experience3 years of experience in a technical role in the medical device industryProject management experience in the medical device industryExperience and understanding of quality system regulations (e.g. 21CFR820, ISO13485).Project management experience in the medical device industryExperience with polymers, medical grade metals and medical packagingHands-on knowledge of electronics, motion control, plastics, metallurgy, and manufacturing processesExperience with polymers, medical grade metals and medical packagingPlease send suitable resumes in confidence to JPCuadra @ openscientific.comAdditional InformationAll your information will be kept confidential according to EEO guidelines.