About this role
• Education / Educación: University level: A Bachelor of Engineering degree.
• 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