Description
ESSENTIAL DUTIES AND RESPONSIBILITIES:* Design and develop tooling, equipment, functional drawings and fixtures for new and existing products to improve quality, cost and productivity
* Evaluate processes to identify areas to improve quality, cost efficiency and employee safety
* Interface daily with in-house and customer engineering teams to identify/resolve problems and implement solutions to stabilize product, including diagnosing, troubleshooting, and resolving equipment down situations.
* Excellent technical writing ability - Protocols and reports for product testing, test method validations, process development, DOEs, customer quotations and proposals
* Supports process development needs of New Product Development projects, including championing Design for Manufacturing and Assembly (DFMA) initiatives on new product designs,
* Knowledge of FDA regulated medical device manufacturing requirements, QSR, cGMP, ISO standard; experience with introduction of new products, and development of new manufacturing processes.
* Knowledge of Class II and Class III interventional devices and implantables
REQUIREMENTS:
* BS in Mechanical Engineering is preferred, and/or equivalent experience
* 5+ years in medical device production/manufacturing, ideally with start-up company experience
* SolidWorks or equivalent experience
* Excellent communication, planning and organizing skills
To find out more about Real please visit www.realstaffing.com