R&D Engineer 1 CR (Temporary 12 months)

Education / Educación: University level: A Bachelor of Engineering degree. 

Specialized Knowledge (Desirable) / Conocimiento especializado (preferible): 

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

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.
• Qualifications / Cualificaciones: 
• Customer Focus
• Problem Solving
• Informing
• Drive for Results