Job Description
Role Descriptions:
Must Have TechnicalFunctional Skills 2-4 years of experience in manufacturing andor 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 andor 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, Essential Skills:
Manufacturing engineer Desirable Skills:
Keyword:
Skills:
EIS :
Medical Device & RegulationsEIS :
Manufacturing Process Knowledge Experience Required:
2-4
