R&D Engineer 2 CR

R&D Engineer 2 CR

Alajuela, Costa Rica

+ **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