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.