R & D Engineer 2 CR (Temporary 12 months)
Hologic
Description
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Education / Educación: University level: A Bachelor of Engineering degree. Equivalent: University diploma or technical certification at least 350 hours.
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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
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Languages required for the position (Desirable) / Idiomas requeridos para el puesto (preferible): Spanish/English
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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.
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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