Manufacturing Engineer

Job Responsibilities: Support the plant manufacturing effort, with ability to identify problems and specific focus will be in areas of improving quality, waste and equipment efficiencies. Application of Transfer functions during troubleshooting and production support (i.e. Statistical Tolerance Analysis, Design for Six Sigma) - Ability to utilizea set of existing tools to aid in the analysis of parts and subsystems. Understanding of Manufacturing Statistical methods, such as process capability and Design of Experiments - Understands and can apply limited statistical tools used to assist in development and troubleshooting of products and processes. Ability to handle projects of a small to moderate scope. Will be required to handle several assignments (project & process duties) simultaneously. Responsible for the recommendation of process modifications, all associated documentation. Understanding on design changes, process improvements, outsourcing, material cost reduction, and other plant efficiency efforts. Core Team MemberRepresentation in assigned plant - Basic understanding on the change process and can execute plans with the guidance of a site lead. CAPA Execution - Understands the process and can complete CAPA activities with a guidance from an SME. Engineering Standards such as ASME Y15.4 - Understands and can apply some elements of various standards to engineering drawings. ISO compliance, FDA 21 CFR 820 compliance, and cGMP efforts - Understands and has knowledge of FDA and ISO regulations and cGMP. Ability to effectively create CAD models, assemblies, and drawings with some guidance from SME. Geometric Dimensioning and Tolerancing – Firm understanding and application of many GD&T specifications. Technical Writing skills as applied to manufacturing documentation and process development - Experienced in the creation and revision of technical documentation. Carries out all other duties and responsibilities as assigned. Demonstrates the ability to follow established procedures according to Good Manufacturing Practices (GMP). Qualifications Knowledge and Skills: Minimum of 2 years of work experience in a manufacturing environment. Preferably in the high-volume production of medical devices. Able to organize and prioritize assignments. Familiar with Manufacturing processes knowledge such as Castings, Injection Molding, Sheet Metal, welding, Machined components - Understands some fabrication methods, Sterilization Process and their applications. Demonstrates excellent written and verbal communication skills ( English and Spanish ) across all levels. Ability to represent functional and operations organization with clarity Supports and drives change management within function Functional or cross functional liaison with stakeholders concerning operational or project deliverables. Ability to manage customer satisfaction initiatives. General knowledge and understanding of the Food and Drug Administration (FDA) 21 CFR 820 and International Organization for Standardization (ISO); minimum 1 year working in a regulated environment. Understanding of Lean Manufacturing initiatives with an emphasis in continuous improvement. Six Sigma certification (greenbelt or blackbelt) preferred. Basic math/statistics skills. Good experience using Microsoft tools and SAP. Willing to work independently and meet deadlines with little supervision. Required Education and Experience: Requires a bachelor's degree in engineering or related field with 2 years of experience in an engineering roleOR MS with at least 1 year of experience in an engineering role. #J-18808-Ljbffr