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 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
