Medical Devices Manufacturing Process Development Engineer
ROLE: - PROCESS DEVELOPMENT ENGINEER
LOCATION: CINCINNATI, OH
The process development Engineer will design and develop medical device mechanical/ electromechanical systems. Assignments are broad in nature, usually requiring initiative, originality, ingenuity and excellent problem-solving skills. Knowledge in the selection of various materials and adhesives for medical devices along with experience designing for high volume manufacturing are key areas. Experience in designing for automated assembly is a plus.
EDUCATION: DEGREE IN MECHANICAL ENGINEERING OR RELATED.
EXPERIENCE: MORE THAN 8 YEARS IN MEDICAL DEVICES MANUFACTURING PROCESS
* Design transfer to manufacturing.
Leading the development of manufacturing processes, verification and validation and design transfer to manufacturing.
Provide inputs to product design team on DFA, DFM...etc.
Provide inputs to product and design verification and validation plans.
Participate in DOE's and maintain records.
Liaison with vendors and suppliers of materials, tools and components.
Well versed with statistical analytical techniques and s/w tools like MATLAB, MINITAB.
Participate in developing prototypes, process and equipment to support manufacturing.
Process verification and validation including IQ, OQ and PQ
Compile documents to meet al Quality, regulatory, PLCP based SOP requirements.
Past experience as a design engineer will be an added advantage.
Project planning - resourcing, timelines, quality and budgets.