Manufacturing Engineer

Manufacturing Engineer

Location: El Paso, Texas

Job 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).

Qualifications

Knowledge and Skills:

• Minimum of 5 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 5 years of experience in an engineering role OR MS with at least 4 year of experience in an engineering role.