R & D Engineer 1 CR (Temporary 12 months)

• Education / Educación: University level: A Bachelor of Engineering degree (Preferably mechanical or electromechanical engineering)

• 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).

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

• 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.