Sunnyvale, CA 94089
* This position entails a high level of organization, excellent communication skills, and rigorous process discipline and documentation to assure functionality, safety, reliability and quality of the product.
* In support of New Product Introduction (NPI) efforts, work with design engineers to optimize design drawings and supplier manufacturing processes so that high quality parts are consistently delivered.
* Design, test, and validate new consumable designs in collaboration with diverse functional groups from initial design to market and manufacturing release.
* Hands‐ on experience with validations, design for manufacture (DFM), material selection, and process development.
* Conduct feasibility studies of the design to determine ability to function as intended.
* Coordinate and drive new and existing consumable part and process qualifications from inception through completion in accordance with FDA and ISO guidelines.
* Maintain detailed documentation throughout all phases of development through manufacturing.
* Develop and document business practices, processes, procedures, and work instructions
* Determine and execute the most appropriate testing to address process and system level performance issues involving cartridge consumables.
* Assist in Problem Solving, Failure Analysis, and Corrective and Preventative Actions with suppliers.
*Promote a culture of structured problem solving.
*Assist suppliers in developing final test requirements to ensure products meet specifications.