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Sr. Manufacturing Engineer for New Product Development H/F – Dispositifs Médicaux – Paris

You will work at a large American group. A good command of English is indeed mandatory for this position.

Job Responabilities : 

– Develop manufacturing processes by understanding product requirements : researching, designing, and testing manufacturing methods and equipment to enhance productivity and product quality. 

– Evaluate manufacturing processes by designing and conducting research programs. 

– Assure new product and process quality by designing testing methods, finished product, and process capabilities. 

– Create process validation master plan. Create equipment specification and software requirements. 

– Participate new product development phase reviews and provide inputs representing manufacturing operations. 

– Create or update production documentations and train production personnel and technicians on processes. 

You hold a Master’s degree in mechanics, biomedical, or related discipline, and have a minimum of 5 years of experience in the medical industry.

Knowledge and Skills : 

– Knowledge and experience in Lean Manufacturing. 

– Strong analytical and problem-solving skills. 

– Ability to define, write, and perform test protocols for manufacturing process development. 

– Ability to create detailed tooling and fixture drawing.

– Understanding of FDA medical device regulation, MDSAP regulations, ISO 13485, design controls and process controls. 

– Ability to create a basic strategy for new product process and equipment development and qualification. Set priority, plan, execute, and implement project from concept to completion independently. 

– Excellent written and oral communication.

– Fluent in English and French.