manufacturing Engineer

Role Descriptions: Must Have Technical/Functional Skills · 2-4 years of experience in manufacturing and/or process engineering. · Strong technical writing skills, with appropriate awareness of intended audience. · Ability to effectively communicate across multiple audiences, including operators, peers and management, in both written and oral manners · Process validation experience. · Experience in a Medical Device and/or regulated manufacturing work environment. · Persuasive communication and interpersonal skills. · Digital literacy, including use of Microsoft Office tools. Roles & Responsibilities · Writing and execution of validation protocols and reports (i.e. IQ, OQ, PQ, etc.) · Developing and implementing manufacturing processes, preparation of specifications and operator instructions, process studies, production readiness, investigations, root cause analysis, problem solving and report or presentation preparation. · Updating procedures, manufacturing specifications, bills, routes and travelers for product & process changes in the PLM system. · Working with OEM equipment manufacturers and distributors to develop user requirements. · Work on new asset commissioning · Working with multi-functional teams (Operations Value Stream, OpEx, Planning, Engineering, and Quality) to align on validation strategy, author validation documents, coordinate execution and document approvals. · Ensuring compliance with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments when supporting projects. · Maintains positive and cooperative communication and collaboration with all levels of employees, customers, contractors, and vendors. Generic Managerial Skills, If any · Experience working in a regulated industry, such as Medical Device. · Experience with machining processes, metal finishing processes, laser processing or production automation. · Hands-on experience with machining processes, casting, metal finishing processes, laser processing or production automation. · Knowledge of statistical data analysis and associated tools (e.g. Minitab). · Basic knowledge of Geometric Dimensioning and Tolerancing (GD&T). Willingness to support global projects, which may include travel Key Words to search in Resume validation protocols, IQ, OQ, PQ, manufacturing processes, process studies, new asset commissioning,