Job Duties
Trouble-shoot manufacturing processes, analyze, design and develop processes, tools, equipment necessary to produce products in a lean manufacturing environment. You will also implement and qualify production equipment and methods, generate testing protocols and reports, and work with supervision and project team direction. In this position you will work closely with team members to support the successful completion of all development project activities, defining, developing, verifying and validating products for successful commercialization. Apply engineering principles to create practical solutions to technical challenges and provide technical support across functions; and establish equipment specifications and requirements in the development of new equipment or improvements to existing equipment.
This position is also responsible for developing design and process failure mode and effects documents; managing process validation activities, including writing protocols and reports, preparing master validation plans and reports, addressing deviations and non-conformities, and making statistically valid conclusions; and developing testing equipment and methods for product/assembly/component testing.

BS degree in Mechanical or Materials Engineering required and a minimum of 3-5yrs experience.
Knowledge of mechanics of materials and strong problem solving skills. ISO/GMP training and project management/leadership skills a strong plus. Experience with statistical and analytical methods and strong mechanical design skills including test methods and test-fixture design required.

All information is Confidential"