Sr. NPI Manufacturing Engineer in Sunnyvale, California at Cepheid

Date Posted: 4/16/2018

Job Snapshot

Job Description

Job ID: CEP000879

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

The Sr. NPI Manufacturing Engineer will support manufacturing operations for the production of diagnostic instruments and New Product Introduction. You will perform troubleshooting and implement changes that improve manufacturing quality and product performance via activities such as historical data analysis, test design, documentation, and the implementation/validation of equipment and process changes. You will work closely with development engineering during the design of products to ensure manufacturability, cost, develop processes for optimum manufacturability, develop manufacturing documentations (specification, drawings) to support build and testing, and directly work with manufacturing/Contract manufacturers to build prototypes, pilot, and production instruments as appropriate


  • Take complete manufacturing responsibility for “mechanism” design implementations into production.

  • Evaluate and challenge mechanism designs for technical merit, reliability, serviceability and manufacturability. Provide suggested change proposals.

  • Provide mechanical design engineers with DFM input to ensure consistency/commonality among hardware and standard part selections across product/sub-assembly lines.

  • Design, document, and create efficient “mid-volume’ manufacturing assembly line including: Workplace and flow process development

  • Specify, document, procure, qualify, and implement fixtures, hand tools and equipment.

  • Determine and incorporate critical feature inspection and test checkpoints into process.

  • Generate formal design documentation, review, and control (e.g. design reviews, Design History Files and Change Orders).

  • Familiar with FDA GMP and design control in regulated environment.

  • Approve design releases to manufacturing, review engineering documentation, and provide vendor and in-house DFM inputs.

  • Review/approve and determine impact of Change Orders from manufacturing and field perspective.

  • Take responsibility for developing and maintaining compliance with the quality system.

  • Evaluate and select suppliers for mechanical parts. Help resolve supplier quality issues.

Job Requirements



Qualifications



  • BS in Engineering: Electrical, Mechanical, Industrial, Manufacturing or an equivalent combination of education and work experience

  • 8-10 years’ experience with industry related. - Proficient in CAD software (SolidWorks, preferred) and Microsoft Office Applications (Word, Excel, Power Point, Visio, Project).

  • Experience working in environments following FDA Good Manufacturing Practices, QSR, and ISO 13485.

  • Excellent verbal and written communication skills required.

  • High degree of attention to details.

  • Strong problem solving and analysis skills

  • Ability to work on and manage multiple projects in a fast-paced environment.



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 62,000 associates is united by a common culture and operating system, the Danaher Business System, which serves as our competitive advantage. We generated $16.9B in revenue last year. We are ranked #133 on the Fortune 500 and our stock has outperformed the S&P 500 by more than 1,300% over 20 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.