Sr. Engineer-Process Validation-Csv-Fmea

Descripción del Empleo:
Responsibilities may include the following and other duties may be assigned. Designs and plans layout for activities such as machining, metal forming, plastics processing, welding and brazing, assembly, and materials handling. Adapts machine or equipment design to factory and production conditions. Designs arrangement of machines within plant facilities to ensure most efficient and productive layout. Designs sequence of operations and specifies procedures for the fabrication of tools and equipment and other functions that affect product performance. May incorporate inspection and test requirements into the production plan. Inspects performance of machinery, equipment, and tools to verify their efficiency, and investigates and initiates corrective action of problems and deficiencies to ensure product quality.
Requisitos:
Minimum 2 years of experience working with Process Validation, CSV and FMEA in a FDA regulated industry. Experience with equipment validation (IQ, OQ, PQ). Experience with medical device products, processing and technologies (endovascular catheter products preferred). Knowledge of Minitab or other statistical software preferred. Cross functional team experience. Bilingual. Bachelor Degree in Engineering Completed. Qualified candidates please send your resume to **********