Description
- Position will focus on implementing tooling, fixtures, processes, etc. into production lines to support increased capacity, reduce cost, improve field reliability, and improve yield.
- Interface with design engineering in coordinating the release of new products.
- Perform engineering work including test of materials, preparation of specifications, process studies, process validations, evaluation of process models and process improvements of product design, development of test fixtures, report preparation and other activities of wide scope requiring broad knowledge of precedents in medical device design and development.
- Assist in the development and management of quality control of manufacturing processes.
- Interface with vendors and other outside specialists.
- Maintain records, training, and reporting systems for coordination of manufacturing operations.
- Carry out responsibilities in accordance with the organization's policies and applicable laws.
This position requires at least 5 years medical device manufacturing experience or other FDA regulated industry and a BS engineering degree or equivalent. Proficiency with medical device development life cycles and manufacturing processes and technologies required. Knowledge of FDA regulations required. Experience with CAD software drafting programs is highly desirable. Demonstrated success with statistical techniques, process control, and process validation is required, as is designing fixturing and documenting processes.
To find out more about Real please visit www.realstaffing.com