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R&D Sustaining Engineer 2 CR

Alajuela, Costa Rica

Education / Educación: A Bachelor of Engineering degree or a similar career.

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

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 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

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.