Minimum 5 years of Medical devices - Manufacturing Engineering experience. Good Experience working on Process Validations (IQ, OQ, PQ) Experience developing manufacturing processes and technologies, which includes process characterization Experience in PFMEA Experience in Data analysis (Minitab) Evaluate process and design alternatives based on Design for Manufacturability principles. Ability to work within a team and as an individual contributor in a fast-paced, changing environment. Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization. Multitasks, prioritizes and meets deadlines in timely manner. Strong organizational and follow-up skills, as well as attention to detail. Understand principles of "Cost of Goods Sold". Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.