Hologic Temp R & D Engineer 1 CR para GSS (temporal por 12 meses) in Alajuela, Costa Rica

Temp R & D Engineer 1 CR para GSS (temporal por 12 meses)

Post Date Jun 05, 2018

Summary of Duties and Responsibilities:

· Supports research, design and development projects including creating tooling and fixtures to meet product and process development needs. The R&D Engineer 1 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

· Support product by troubleshooting product, process and component issues

· 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.

· Support 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

· Execute Protocols and laboratory notebook studies.

· Support in modeling components and assemblies in CAD and create detailed drawings

· Coordinate work with outside vendors and internal personnel including material procurement and testing.

· Support completion of Design History File Documentation per FDA requirements

Qualifications:

· Hands-on engineering skill with a proven ability to work well in a team environment

· Comfortable with all phases of the product development lifecycle, including design, implementation, verification, qualification, transfer, and maintenance

· Solid understanding of design principles for reliability and manufacturability

· Excellent oral and written communication skills

· Understanding of design control process for medical devices is preferred

· Demonstrated ability to work independently, resolve issues and manage multiple tasks

· Adaptable and flexible personality

Education:

· University level: A Bachelor of Engineering degree.

Experience:

· At least 1 years’ experience in the related field, a medical device industry.

Specialized Knowledge:

· Competency in statistical analysis and tools (Minitab preferred)

· Proficiency using CAD tools (SolidWorks preferred)

· Familiar with Good Laboratory Practices and QSR (Quality Systems Regulations)

· Advanced English

· Microsoft office

· Basic knowldege using CAD tools (SolidWorks).