Demonstrate knowledge and responsibility for GMP's/QSR and ISO requirements.
Evaluate and trouble-shoot manufacturing processes in an outsourced environment.
Analyze, design and develop processes, tools, equipment necessary to produce products in a lean manufacturing environment.
Support the successful completion of all manufacturing project activities, defining, developing, verifying and validating products for successful commercialization.
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 as appropriate.
Analyzes and assesses designs and plans layout for activities including machining, metal forming, plastics processing, welding and brazing, assembly, and materials handling.
Develop, implement and qualify production tooling for components, assemblies and packaging.
Develop and execute test methods and reports to assure appropriate design and process validation.
Develop process controls leveraging statistical process control and data analysis.
Provides design input to R&D engineering including appropriate Design for Manufacture (DFM) and Assembly (DFA) analyses.
Provides operations engineering input to develop risk analyses and abatement plans and actions.
Performs tool qualifications and validations including IQ, OQ, and PQ’s.
Utilizes advanced problem solving techniques and skills to rapidly resolve and implement technical solutions in alignment with project and organizational objectives.
Other duties may be assigned.
What We’re Looking For:
Bachelor's degree in: Electromechanical Engineering, Materials Engineering or Mechanical Engineering.
English Level desired: Advanced
Experience:2+ years’ experience in Medical Device Manufacturing (ISO13485), Problem Solving, Equipment Qualifications, Process Validations, Lab Studies, Process Characterization, Tolerance Stack up Analysis, Good Documentations Practices, Knowledge in Statistics,