Product Improvement Engineer II for Cepheid in Sunnyvale, CA to be focusing on instruments/software/consumables, work with the Product Transfer team in transferring new products into assay manufacturing and sustaining them over their lifecycle. Support and lead assay feasibility, qualification, and implementation activities. Develop expertise in risk/impact assessments and provide guidance to cross-functional teams on technical requirements and project direction. Develop a nuanced technical understanding of the integration of Cepheid products. Partner with R&D, Engineering, Software, Technical Operations, and Quality teams to assess and design for compatibility with Cepheid manufacturing throughout the life cycle of products. Lead, coordinate, or participate in operations-related activities required for the transfer/sustainment of instruments, software, and consumables into assay manufacturing. These activities include: prototype and qualification builds/testing; IQ/OQ/PQ; test method and Process Validation; development and maintenance of production documentation including procedures, worksheets, and bills of materials. Troubleshoot challenges throughout the life cycle of products. Design and execute experiments as part of these investigations.



Education Required: Bachelor's degree in Mechanical Engineering, Bioengineering, Manufacturing Engineering or related field (willing to accept foreign education equivalent) plus two (2) years of experience as an engineer or in a related occupation diagnosing and resolving technical issues and providing technical recommendations in a manufacturing setting. Experience must include: Conducting risk/impact assessments: dFMEA, pFMEA, etc.; Designing/executing experiments as a part of failure/troubleshooting investigations, product development, and/or as a part of qualifications/validations; Organizing and preparing technical reports/summaries: i.e. qualifications, failure investigations, development studies, etc.; Applying understanding and use of statistical techniques for data analysis: i.e. t-test, ANOVA, DOE, etc.; Conducting quantitative data analyses using tools such as: Excel, JMP, Minitab, PowerBI, etc.; Working within an Operations function (Manufacturing, Quality, and/or Technical Operations) in a regulated industry; and Working with one or more of the following: batch records, bills of materials, logistics and inventory parameters, costing parameters, document management systems, and/or ERP systems. Partial telecommute available.

Salary Range: $81,100 - 141,900. Offered Salary: $113,630. Submit resume melissa.emerling@cepheid.com and reference job title.