The Validation Engineer is responsible for developing, documenting, and validating manufacturing processes, related to the manufacture, inspection, and packaging of lathed intraocular lenses. Specific tasks to include: new technology and process improvements for existing manufacturing processes, lathe and milling competency, optics knowledge, leadership support for increasing product quality and process productivity enhancements, support for new process transfer into production and other projects which may be assigned by the Engineering Manager. Knowledge of cGMPs for medical devices a plus, strong technical writing skills.
Responsibilities
Conduct Engineering studies, DOE's and process/equipment validations including preparing protocols, supporting execution of protocols and summarizing/analyzing results.
Support development of operating procedures and training of manufacturing technicians.
Manage the design and development of new equipment, tooling, or fixtures to be used in the manufacture, inspection, sterilization, or packaging of intraocular lenses or related ophthalmic devices.
Technical interface with component vendors to communicate part requirements, to resolve technical issues, and to develop long term reliability of vendor supplied parts.