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Consumables Engineer

Sunnyvale, CA

Post Date: 10/05/2017 Job ID: 8131 Industry: Software Engineer Pay Rate: Not Specified
As a Diagnostic Consumables Engineer, you will be a part of a fast‐ pace, multi‐ disciplinary, and creative team that drives new product development and implements continuous improvements to new and existing processes. The ability to help develop products, trouble‐ shoot, define root cause, provide resolution, and implement the necessary changes efficiently in an FDA regulated environment is critical. The ability to identify problem and create a solution through research and solid technical principles/disciplines is necessary; must be able to interface well with other engineers, scientists, vendors, and operations personnel.

Responsibilities:
* 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.
Qualifications: * Experience with High Volume manufacturing processes, including machining, extrusion, molding, ultrasonic welding. * Experience with GDT (Geometric Dimensioning and Tolerancing), quality measurement technique and use of SolidWorks. * Solid mathematical skills with basic statistics knowledge. * Working knowledge of GMP, ISO, and FDA rules and regulations is highly desirable. * Working knowledge of design of experiments (DOE), Failure Mode Effects Analysis (FMEA), * Statistical Process Control (SPC) and interpretation of test results is highly desirable. * Strong analytical and troubleshooting skills to understand system interfaces and be able to quickly analyze, troubleshoot, and resolve system interoperability problems is highly desirable. * Bachelor's degree in Engineering plus 3‐5 years of related work experience with a good understanding of specified functional area or equivalent combination of education and experience to perform at this level. Nice to have skill sets: * Experience with failure investigations and root cause failure analysis. * Process Development, DAMIC

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