Diagnostic Consumables Engineer in Sunnyvale, California at Cepheid

Date Posted: 10/1/2018

Job Snapshot

Job Description

Job ID: CEP002232

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 successful candidate will be the technical lead with subject matter expertise for the design and development of consumable plastic components for medical device product(s) manufacturing.  Investigates and evaluates existing technology, current capabilities, and product requirements to develop component specifications that enable efficient manufacturing for sustainable, large-scale consumables production. The successful candidate must be able to use their knowledge of mechanical design, GD&T practices, materials and injection molding processes to engineer custom solutions, develop DFM feedback, improve current designs, interface with vendors, and enable large scale manufacturing of consumables for the medical device industry. They will use their experience in consumables manufacturing to transition designs from the Concept phase through Design and Development and into Production. Through these phase gates of product development and/or new product introduction, the successful candidate will apply DFMECA, DFM, and CAE tools to develop robust component designs that encourage manufacturing efficiencies for injection molding through finished device assembly.  They will actively sustain and support re-qualifications of existing parts and molds throughout the product lifecycle. This is a hands-on position involving detailed design (3D modeling and 2D print specifications), testing, prototype fabrication and Engineering support of Production; must be able to interface well with other engineers, scientists, vendors, and operations personnel. There are no direct reports to this position.

  • Responsibilities:

    - Maintain and/or improve existing consumables parts production, with an emphasis on refining part specifications, improving manufacturability, and maintaining integral product quality and performance.   

    - Manage component specifications in Quality Management System (QMS) and ensure those specifications are applicable to product function and Cepheid's Quality Policy.  

    - Use CAD modeling, prototyping, molding simulation CAE data, and hands-on lab testing to develop and enhance part attributes, mold concepts, and mold design details.

    - Proactively identify risks in the design of parts, molds, and methods associated with consumables manufacturing and design quality into the component design rather than relying on inspection to detect non-compliance with design or process intent.  
    - Establish working relationships with vendors for outsourcing of engineering services, materials supply, injection molding tool design, and contract manufacturing of consumables components.

    - Enforce high standards for all consumables products such that the design intent, quality expectation for patient safety, and finished medical device function are never compromised.  
    - Design, test, and validate new consumable designs in collaboration with multi-disciplined engineering teams.
    - Assist in failure investigations and root cause analyses as they relate to consumables parts performance.
    - Coordinate Engineering testing, first article inspections, and qualification activities.  

    - Objectively utilize advanced inspection technologies, statistical methods, process data, DOE, and root cause analyses to identify required improvements to injection molding tools, processes, and measurement techniques such that robust performance at high manufacturing efficiencies is enabled.  
    - 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.
    - Actively participate in group meetings and be a technical point person in project teams.

    - Ability to prioritize and manage multiple, concurrent projects in a fast paced environment.

    - Create custom fixtures and procedures for testing, inspection, or functional evaluation of consumables parts designs and compliance with specifications or intended use.
    - Work with Manufacturing Engineering to create initial BOMs and updated models as required. 


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 large-scale injection molding with a minimum of 2-4 years of direct related experience.

    - Fundamentals of plastics material properties, molding process development, and tooling design.

    - Excellent verbal and written communication skills.
    - Proficiency with SolidWorks, MiniTab, and Microsoft Office applications.
    - Experience with creating drawings, BOMs, product specifications, and engineering drawings.

     

    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.