Senior Process Engineer

Organization
Cepheid - US
Job Location
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Sunnyvale, CA 94089
Job Description

The Senior Process Engineer is responsible 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. Develop strategy, change management plan, and execution plan to improve flow of products. Leverage process knowledge to identify opportunities / solutions to improve throughput capacity by reducing impact of constraints. Is responsible for driving assemblers' engagement and for developing Lean and Six Sigma capabilities through coaching and mentoring. Responsible for performing process qualifications for new and existing production lines. Follow and observe all regulatory requirements (GMP's, ISO, FDA, internal policies) applicable to area of responsibility. The ideal candidate should have extensive experience with automation lines 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/Procedures.
  • 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).
  • Update and create manufacturing work instructions, facilitate changes and manage implementation of changes to manufacturing documentation (examples: Bills of material, routers, drawings) for a specific high volume manufacturing production line.
  • Must be able to work within operating procedures to identify, change, justify, and implement process improvements to process capability, equipment availability, and yield improvement.
  • Must be able to utilize and leverage ongoing data and convert information into actionable procedures and reaction/escalation plans aligned with maintaining validated state of Class II and Class III automated equipment.
  • The role will develop validation documentation for line extensions and process improvements and is the manufacturing liaison for all process qualifications. The role will facilitate training during the transition between design validation and product.
  • Must be able to work collaboratively in a matrix environment to implement solutions addressing problems associated with commercial production. Must be able to partner effectively during root cause investigation through resolution with functional representatives of regulatory, automation, molding/tooling, production and quality.
  • The role will help facilitate communication of issues through an escalation process leveraging common templates and will consolidate and document root cause through resolution.
  • Bachelor's degree in Engineering/related discipline or equivalent combination of education and experience to perform at this level
  • A minimum of 7 years overall related business experience in Manufacturing preferably in medical device
  • Experience with Lean and Six Sigma
  • Experience with Project Management

 

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