Manufacturing Engineer

Job Description

Responsibilities:

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• Support the plant manufacturing effort, with ability to identify problems and specific focus will be in areas of improving quality, waste and equipment efficiencies.

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• 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.

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• Understanding of Manufacturing Statistical methods, such as process capability and Design of Experiments.

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• Understands and can apply limited statistical tools used to assist in development and troubleshooting of products and processes.

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• Ability to handle projects of a small to moderate scope. Will be required to handle several assignments (project & process duties) simultaneously.

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• Responsible for the recommendation of process modifications, all associated documentation.

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• Understanding design changes, process improvements, outsourcing, material cost reduction, and other plant efficiency efforts.

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• Core Team Member Representation in assigned plant - Basic understanding on the change process and can execute plans with the guidance of a site lead.

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• CAPA Execution - Understands the process and can complete CAPA activities with guidance from an SME.

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• Engineering Standards such as ASME Y15.4 - Understands and can apply some elements of various standards to engineering drawings.

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• ISO compliance, FDA 21 CFR 820 compliance, and cGMP efforts - Understands and has knowledge of FDA and ISO regulations and cGMP.

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• Ability to effectively create CAD models, assemblies, and drawings with some guidance from SME.

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• Geometric Dimensioning and Tolerancing Firm understanding and application of many GD&T specifications.

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• Technical Writing skills as applied to manufacturing documentation and process development - Experienced in the creation and revision of technical documentation.
  nCarries out all other duties and responsibilities as assigned.

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• Demonstrates the ability to follow established procedures according to Good Manufacturing Practices (GMP).

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Requirements:

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• 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.
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• 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.
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• Familiar with Manufacturing processes knowledge such as Castings, Injection Molding, Sheet Metal, welding, Machined components - Understands some fabrication methods, Sterilization Process and their applications.
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• Demonstrates excellent written and verbal communication skills ( English and Spanish ) across all levels.
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• Ability to represent functional and operations organization with clarity
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• Supports and drives change management within function
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• Functional or cross functional liaison with stakeholders concerning operational or project deliverables.
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• Ability to manage customer satisfaction initiatives.
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• 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.
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• Understanding of Lean Manufacturing initiatives with an emphasis in continuous improvement.
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• Six Sigma certification (greenbelt or blackbelt) preferred.
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• Basic math/statistics skills. Good experience using Microsoft tools and SAP.
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• Willing to work independently and meet deadlines with little supervision.
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Qualifications:
Additional Information

All your information will be kept confidential according to EEO guidelines.