The Process Development Engineer leads the operational readiness during new product development and manufacturing changes for a variety of medical device products. The Process Development Engineer is responsible for the design for Manufacturability/Assembly feedback on the design, completing Process Failure Mode and Effects Analyses, leading the transfer builds, ensuring all processes are validated, and executing on all design transfer deliverables.
As the Process Development Engineer you will re responsible for the designing and optimizing of processes required to manufacture new medical devices.
- Process development and optimization through Design of Experiments (DOE)
- Root Cause Investigation utilizing statistical software and process analysis tools such a process mapping, fishbone diagrams
- Ensure that operations requirements are incorporated into designs during products development
- Provide leadership to manufacturing locations serving as the communication bridge between the New Product Development team and the manufacturing locations
- Develop advanced manufacturing systems and processes to ensure process capability, reparable & reproducible in launched product
- BS in Engineering, preferably Mechanical Engineering or Industrial Engineering
- Minimum of 3 years of process development engineering preferably within the medical device industry
- Green Belt or Black Belt Certification is a plus
- Manufacturing operation experience is a plus
- Equipment Factory Acceptance Testing/SAT
- Experience with process development and optimization
- Process Validation (IQ, OQ, PQ) & Equipment IQ, OQ
Sthree US is acting as an Employment Business in relation to this vacancy.