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Process Engineer in Sunnyvale, California at Cepheid

Date Posted: 5/11/2019

Job Snapshot

Job Description

Job ID: CEP003362

About Us

At Cepheid, we are passionate about improving healthcare through faster, more accurate diagnostic tests. With our GeneXpert® System, we’ve taken the most sophisticated molecular technology and packaged it into an automated, easy-to-use format that has quickly become the platform of choice worldwide. From the largest laboratories to small physician offices, our game-changing solution delivers critical answers when clinicians and patients need them most. Through strong molecular biology capabilities and ongoing product innovation, we are focused on developing tests for healthcare-associated infections, sexual health, critical infectious disease, virology, and oncology applications. Come join our vision for a better way and help make life better for us all! For more details, visit us at www.cepheid.com or follow us on Twitter (@CepheidNews).


Description

  • Job Description Summary
    The 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. Process Engineer will help execute change management plan, and execution plan to improve flow of products. The Process Engineer will also leverage process knowledge to identify opportunities / solutions to improve throughput capacity by reducing impact of constraints.

    Defines processing or handling equipment requirements and specifications, and reviews processing techniques and methods applied in the manufacture, fabrication, and evaluation of products. Involvement may begin at any step from pilot plant to full-scale manufacturing. Coordinates design requirement review with appropriate engineering/scientific personnel to ensure compatibility of processing methods. Compiles and evaluates test data to determine appropriate limits and variables for process or material specifications. May conceive and plan projects involving definition and selection of new concepts, equipment automation technology, and approaches in the processing or development of new or improved processes.
  • Job Description
    • 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. 
    • 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.
    • 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.
    • Work within operating procedures to identify, change, justify, and implement process improvements to process capability, equipment availability, and yield improvement.
    • 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.
    • Develop validation documentation for line extensions and process improvements and is the manufacturing liaison for all process qualifications.
    • Facilitate training during the transition between design validation and product.
    • Partner effectively during root cause investigation through resolution with functional representatives of regulatory, automation, molding/tooling, production and quality.
    • Facilitate communication of issues through an escalation process leveraging common templates and will consolidate and document root cause through resolution.

Job Requirements



Qualifications

MINIMUM REQUIREMENTS:

  • Education or Experience (in years): Bachelor’s degree in Engineering/related discipline or equivalent combination of education and experience to perform at this level

  • A minimum of 2-4 years overall related business experience in Manufacturing preferably in medical device
  • Knowledge and skills: 

  • Experience with Lean and Six Sigma - Experience with Project Management  
  • The ideal candidate should have experience with automation lines and developing process documentation.  
  • Must be able to work collaboratively in a matrix environment to implement solutions addressing problems associated with commercial production.
  • In depth understanding of production and quality control techniques (such as CFM and TQM).
  • Understanding of financial processes (standard cost development) and business planning.


Danaher Corporation Overview

Danaher is a global science & technology innovator committed to helping our customers solve complex challenges and improve quality of life worldwide. Our world class brands are leaders in some of the most demanding and attractive industries, including life sciences, medical diagnostics, dental, environmental and applied solutions. Our globally diverse team of 71,000 associates is united by a common culture and operating system, the Danaher Business System, which serves as our competitive advantage. We generated $19.9B in revenue last year. We are ranked #162 on the Fortune 500 and our stock has outperformed the S&P 500 by more than 5,200% over 25 years.
At Danaher, you can build a career in a way no other company can duplicate. Our brands allow us to offer dynamic careers across multiple industries. We're innovative, fast-paced, results-oriented, and we win. We need talented people to keep winning. Here you'll learn how DBS is used to shape strategy, focus execution, align our people, and create value for customers and shareholders. Come join our winning team.
Danaher is committed to competitive compensation that typically has key components including base salary, variable annual incentive compensation based on personal and company performance, and long-term incentive.