Senior Process Engineer

Organization
Cepheid
Job Location
Sunnyvale, CA 94089
Job Description

The Senior Process Engineer is responsibile for developing a strategy and executing plan to deliver process performance improvements related to Safety, Quality, Delivery, and Cost of a manufacturing process or line. Develops strategy, change management plan, and execution plan to improve flow of products. Leverages process knowledge to identify opportunities / solutions to improve throughput capacity by reducing impact of constraints. Is responsible for driving operators’ engagement and for developing Lean and Six Sigma capabilities through coaching and mentoring. Follows and observes all regulatory requirements (GMP’s, ISO, FDA, internal policies) applicable to area of responsibility. Has extensive experience with bulk liquid manufacturing and
lyophilized reagents and developing process documentation.

 

 

  • Apply knowledge of relevant continuous improvement tools and approaches to increase production up-time, minimize unplanned maintenance, minimize work in process inventories (WIP) or plant inventories, and implement cost reduction initiatives across equipment and labor
  • Assist in creating and updating manufacturing SOPs/Work Instructions.
  • Provide training to Manufacturing personnel
  • Seek and implement process improvements within Manufacturing
  • Recognize machine operating conditions and requirements for optimum production runs and can troubleshoot and resolve basic line performance issues
  • Identify constraints in, or non-conformances resulting from, the production process through analysis of material, people and information movement/flow
  • Understand product cost drivers by interpreting product bill of materials and cost sheets to ensure adherence to projected cost
  • Leverage knowledge of product costs and drivers and Design to Value concepts to effectively participate in cross-functional teams pursuing product cost improvement initiatives
  • Effectively interface with other engineering disciplines, such as Controls & Automation engineering and New Product Introduction teams
  • Develop and deliver oral and written communications around process improvement projects
  • Organize an analytical approach to problem solving with familiarity with FDA and GMP
  • Understanding of financial processes (standard cost development) and business planning
  • In depth understanding of production and quality control techniques (such as CFM and TQM)

 

Requirements
  • Bachelor’s degree in Engineering or a related discipline; or equivalent combination of education and experience to perform at this level.

  • A minimum of 7 years overall related engineering experience within medical device or a regulated industry.

  • Strong analytical and troubleshooting skills to understand system interfaces and be able to quickly analyze, troubleshoot, and resolve system interoperability problems

  • Experience with failure investigations, root cause failure analysis, process engineering, etc.

  • Fluent in the use of MS Excel for data analysis and presentation in graphic formats

  • Solid mathematical skills with basic statistics knowledge

  • Working knowledge of design of experiments and interpretation of test results

  • Excellent communication skills. Must be able to communicate verbally in an efficient and effective manner and be proficient in document preparation and editing, including detailed test planning and report writing. Must be able to reduce data to coherent form for clear presentation.

  • Must have ability to meet deadlines on multiple concurrent projects

  • Must have demonstrated ability to communicate and coordinate efficiently across multiple functions and employee levels

  • Self-directed requiring minimum supervision

 

 

 

How to Apply

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