Job Summary

Manufacturing Engineer for the state-of-the-art facility in El Paso, Texas. Responsible for the implementation of project and process support activities toward attainment of departmental and plant goals. Primary focus in areas of capacity expansion, quality/waste improvement and cost improvement programs. Required to handle multiple assignments of varying scope and complexity.  Ability to read, write and speak in English and Spanish.

Key Responsibilities

• Perform setup and adjust necessary equipment for infection prevention products samples build. Construct samples to simulate the design changes.
• Develop and execute engineering studies to evaluate the product performance due to mold modifications and implement packaging changes.
• Support Equipment purchasing, execute tests, validation runs on manufacturing area.
• Create inventory logs and manage material inventories for different products.
• Support the team with logistics, shipping of product samples and organize the storage of testing materials.

• Create Master Validation Plan, Design Transfer Plan, process work instructions for component/ manufacturing changes and qualify the components. Creating/ reviewing Process validation (IQ/ OQ/PQ) protocols and reports.
• Create/update Standard Operating Procedures & Manufacturing Work Instructions. Coordinate the execution of Process validation.
• Creation/ Closure of Change Control procedure to implement: Manufacturing procedures, Drawings, Artworks, Drawings, Raw material specifications, Inspection plans and others.

• Create base structure items such as BOMs, routers.
• Troubleshooting Manufacturing Issues and general floor support across production lines - Ability to assist with infection prevention products and processes implemented in the assigned plant.

• 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).

Skill Requirements

• Minimum of 6 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 mechanical engineering or related field with 6 years of experience in an engineering role OR MS with at least 5 year of experience in an engineering role.

Other Requirements