Competency in statistical analysis and tools (Minitab preferred)
Proficiency using CAD tools (SolidWorks preferred)
Familiar with Good Laboratory Practices and QSR (Quality Systems Regulations
Knowledge of plastic/metals processing
Knowledge in Tolerance Analysis Stack Up
Qualifications / Cualificaciones:
Customer Focus
Problem Solving
Informing
Drive for Results
Languages required for the position (Desirable) / Idiomas requeridos para el puesto (preferible): Spanish/English
Computer tools and knowledge level required (Desirable) / Herramientas informáticas y nivel de conocimiento requerido:
Basic Skills in Microsoft Word, Excel, Outlook, Power Point and other office software programs.
Knowledge using CAD tools (SolidWorks).
Summary of Duties and Responsibilities / Resumen de funciones y responsabilidades:
Supports research, design and development projects including creating tooling and fixtures to meet product and process development needs. The R&D Engineer 1 performs a variety of duties that require creativity and innovation.
Assume technical role on a cross-functional team on new products, design changes, process changes, design for manufacturability, and product enhancements including related testing, tooling and fixtures.
Propose solutions to design, process, and quality issues through the application of engineering principles, analysis, and empirical methods.
Act a liaison between R&D New Product and Manufacturing Engineering.
Create and maintain accurate documentation of prototype concepts, tooling, drawings and shop orders in coordination with the Quality Assurance and manufacturing functions.
Support prototype and pilot production of new products, product changes, and enhancements in coordination with the Manufacturing and Quality Control functions.
Troubleshoot process and component issues to support process implementation.
Propose designs of prototype fixtures and establish methods to support design verification activities.
Execute test methods, generate protocols and complete reports for design verification, and design validation; support process validation activities.
Execute and create Protocols and laboratory notebook studies.
Create modeling components and assemblies in CAD and create detailed drawings.
Coordinate work with outside vendors and internal personnel including material procurement and testing.
Provide maintenance of Design History File Documentation per FDA requirements.