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Process Engineer – Consumables Automation & Assembly in Sunnyvale, California at Cepheid

Date Posted: 11/18/2018

Job Snapshot

Job Description

Job ID: CEP002329

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

Process Engineer – Consumables Automation & Assembly

The successful candidate will be responsible for the assembly process design and development of consumable plastic components for medical device product(s).  Possesses the skill set to evaluate current capabilities, available technology in the industry, and product requirements to develop assembly methods, processes and drive equipment design to enable efficient large-scale medical device manufacturing.  Must be able to use their knowledge of mechanical design and statistical analysis to develop assembly processes, give component design feedback, and interface with vendors to drive continuous improvement. They will use their experience in high speed automation and assembly environments to support the validation and verification of consumables from the Concept phase through Design and Development and into Production. They will actively sustain and support re-qualifications of existing parts, molds, and equipment throughout a product lifecycle.

This is a hands-on position involving concept development, process and part characterization, and engineering support of Production; must be able to interface well with other engineers, scientists, vendors, and operations personnel. Strong experience with high speed assembly of plastic components with the use of Ultrasonic Welding is desired. There are no direct reports to this position.

Responsibilities:

  • Define, document, maintain and/or improve automation and assembly methods, equipment, and processes for consumable plastics, with an emphasis on improving manufacturability and maintaining integral product quality and performance.   
  • Use 3D CAD modeling, statistical analysis, and hands-on bench or line testing to characterize part attributes, process performance, and assembly characteristics. 
  • Design, test, and validate new consumable processes and/or designs in collaboration with a diverse functional engineering team.
  • Create custom fixtures and procedures for testing, inspection, or functional evaluation of consumables parts designs and compliance with specifications or intended use.
  • The successful candidate work to establish process definition on new production lines and major equipment and start up, insuring all process conditions and measurements are defined, documented, and tested.
  • Assist in failure investigations and root cause analyses as they relate to consumables parts performance in high speed automation environments.
  • Coordinate Engineering testing, first article inspections, and qualification activities for validation and verification of consumables components.  
  • Write verification and validation protocols and related technical reports to support the transfer of designs into Production and document status of consumables throughout a product lifecycle.
  • Create custom fixtures and procedures for testing, inspection, or functional evaluation of consumables parts designs and compliance with specifications or intended use.
  • Actively participate in group meetings and be a technical point person for assembly processing in project teams.
  • Ability to prioritize and manage multiple, concurrent projects in a fast paced environment.

    Job Requirements



    Qualifications

    Minimum Requirements:

    • BS in Mechanical, Plastics, or Manufacturing Engineering or equivalent combination of education and experience to perform at this level.
    • Working knowledge of GMP, ISO, and FDA rules and regulatory requirements.
    • Proven experience with DOE’s, high speed automation or assembly equipment with a minimum of 3-5 years of direct related experience.
    • Excellent verbal and written communication skills.
    • Proficiency with SolidWorks, MiniTab, and Microsoft Office applications.
    • Experience with creating drawings, BOMs, product specifications, and engineering drawings interpretation (GD&T).

    Preferred Requirements:

    MS/MBA preferred a plus.
    Project management experience would be a plus.
    Quality Management System experience preferred.



    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 67,000 associates is united by a common culture and operating system, the Danaher Business System, which serves as our competitive advantage. We generated $18.3B in revenue last year. We are ranked #162 on the Fortune 500 and our stock has outperformed the S&P 500 by more than 1,200% 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.