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R&D Engineer 2 CR

hace 3 semanas


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  • Education / Educación: A Bachelor of Engineering degre (Preferable: Electrical engineering or Mechatronics engineering)

  • Experience / Experiencia: At least 2 years experience in the related field, with 1-2 in a medical device industry. Manufacturing experience a plus.

  • 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)
  • Familiar with plastics and metal components processing
  • Tolerance stack up Analysis demonstrated experience

  • 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.
  • CAD tools demonstrated experience (SolidWorks)
  • Measurement and laboratory equipment experience.

  • 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 2 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.
  • Provide technical expertise of 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
  • Develop test methods, generate protocols and complete reports for design verification, and design validation; support process validation activities
  • Develop Protocols and laboratory notebook studies.
  • Create and maintain 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 and completes new documentation of Design History File per FDA requirements