Process Engineer for Cepheid in Lodi, CA to provide process engineering sustainment coverage. Responsible for performing process qualifications for new and existing production lines. Follow and adhere to regulatory requirements (gMP, ISO, FDA) applicable to area of responsibility. Generate manufacturing SOPs/WIs for new processes and equipment. Provide training to Manufacturing personnel. Develop validation documentation for line extensions and process improvements and serve as the manufacturing liaison for all process qualifications. Partner effectively during root cause investigation through resolution with functional representatives of regulatory, automation, molding/tooling, production and quality. Develop and deliver oral and written communications around process improvement projects. Organize an analytical approach to problem solving with familiarity with FDA and GMP.



Multiple positions.



Education Required: Bachelor's degree in Mechanical Engineering, Industrial Engineering, or closely related field (willing to accept foreign education equivalent) plus two (2) years of experience i as a manufacturing engineer, industrial engineer or in a related occupation in an industrial engineering role applying Lean and Six Sigma or, alternatively, a master's degree in Mechanical Engineering, Industrial Engineering, or closely related field (willing to accept foreign education equivalent) and one (1) year of experience i as a manufacturing engineer, industrial engineer or in a related occupation in an industrial engineering role applying Lean and Six Sigma. Experience must include: Application of PSP tools to increase machine OEE, reduce machine downtime and increase quality; Use of Problem-Solving tools such as 5-why, Fishbone diagrams, Fault-Tree and 8D to drive Root-cause analysis and increase OEE; Use of problem solving tools to drive Root-cause analysis, i.e. 4-6M Fishbone, 5-Why, Fault-tree, and 8D; Design Automation assembly parts and manufacturing drawings via use of CAD- SolidWorks; Statistical analysis/software, i.e. Minitab and MS Excel to develop Statistical Process Control over production KPIs (Parts-per-Day (PPD) and Reject%); Revision of design of test fixtures and automation assemblies from concept to reality by application of Design for Manufacturing and Assembly (DFMA) in SolidWorks; Serving as line auditee for inspections and audits; Working with vendors for procurement, prototyping and fabrication, adhering to budget constraints; Using Engineering Project Management techniques and MS Project to define Technical project scope, cost and timelines and perform resource levelling to accommodate unexpected deliverables; and Application of ROI, Standard Cost Development, and business planning. Experience may be gained through any combination of employment, internship and graduate studies. Salary Range: $103,000 - 180,300/year. Salary Offered: $136,620/year. Submit resume to melissa.emerling@cepheid.com and reference job title.