Sr. Manufacturing Engineer Job at People With Chemistry in San Jose
People With Chemistry, San Jose, CA, United States
Why join our team? Here, you'll work with a team that is pushing the boundaries of medical imaging technology, directly contributing to life-saving innovations. This is an exciting opportunity to be part of a fast-growing startup where your contributions will have a direct impact on healthcare outcomes. Desired experience ? 4 or more years of experience in the manufacturing of Class-II or III small disposable devices in a Cleanroom environment. ? Experience in the manufacturing of diagnostic or therapeutic medical equipment ? Experience with component manufacturing processes (i.e. injection molding, plastic extrusions, machining, sheet metal etc) ? Strong understanding of product development and manufacturing processes in accordance with GMP, FDA QS regulations, ISO 13485 ? Proficiency in SolidWorks, MS-Word, Excel Responsibilities: ? Work cross-functionally to transfer design of new or updated products to Production ? Develop manufacturing processes, process instructions, and testing instructions ? Create and maintain manufacturing tool/equipment drawings and manufacturing documentation in coordination with the Quality System. ? Perform installation and qualification of manufacturing fixtures and/or equipment ? Create, review, and approve design change, and maintain accurate documentation of concepts, designs, and processes. Education Requirements: ? BSME or related discipline