Manufacturing Engineer
Manufacturing Engineer
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Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
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 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 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).
Requirements:
- Requires a bachelors 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.
- 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.
Additional Information :
All your information will be kept confidential according to EEO guidelines.
Remote Work :
No
Employment Type :
Contract
Employment Type
Contract
