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Omni Inclusive

Manufacturing Engineer Job at Omni Inclusive in El Paso

Omni Inclusive, El Paso, TX, US, 88568

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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 utilize a 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 Member Representation 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 role OR MS with at least 1 year of experience in an engineering role.