Tooling Engineer in Sunnyvale, California at Cepheid

Date Posted: 10/13/2018

Job Snapshot

Job Description

Job ID: CEP002119

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 tooling concepts for consumable plastic components for medical device manufacturing. Investigates and evaluates existing technology, current capabilities, and product requirements to develop tooling specifications that enable efficient manufacturing for sustainable, large-scale consumables production (>30MM units annually).
The successful candidate must be able to use their knowledge of mechanical design, thermoplastic materials, injection molding tooling, and systematic processing approaches to engineer custom solutions, develop DFM feedback, improve current designs, interface with vendors, and enable usage of best in class technology for consumable plastic components.
They will use their experience in all phases of a product lifecycle to transition designs from the concept phase (prototyping) through Design and Development (small scale feasibility) and into Production (new product introduction). Through these phase gates of product development and/or new product introduction, the successful candidate will apply D/PFMECA, DFM, and CAE tools to develop robust tooling designs that encourage manufacturing efficiencies for injection molding through finished device assembly. 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 tooling specifications, proposing tooling concepts that leverage best in class technology for medical component manufacturing, and maintaining integral product quality and performance.   
    • Manage tooling component, subassembly, and complete assembly specifications in SolidWorks ePDM and Quality Management System (QMS) and ensure those specifications are applicable to product function and Cepheid's Quality Policy and associated standards.  
    • Use CAD modeling, prototyping, molding simulation CAE data, and hands-on testing to develop and enhance molding technology, process robustness, and provide technical feasibility assessments of new tooling concepts. 
    • Design, test, and validate new tooling concepts in collaboration with multi-disciplined engineering teams.
    • Proactively identify risks in the design of parts, molds, and methods associated with injection molded consumables. 
    • Enforce high standards for all consumables products such that technical issues are resolved and continuous improvement is relentlessly pursued. 
    • Objectively utilize statistical methods, process data, DOE, and root cause analyses to identify required improvements to injection molding tools and processes such that robust performance at high manufacturing efficiencies is enabled.  
    • Write verification and validation protocols and related technical reports to support new tool builds, with ability to articulate statement of work itemization to both internal and external parties. 
    • Actively participate, interface with, and coordinate with cross functional teams consisting of internal and external parties as a technical point person. Those parties may include external suppliers and internal Engineering and Operations departments. 
    • Ability to prioritize and manage multiple, concurrent projects in a fast-paced environment.
    • Support company goals and objectives while following company policies and procedures.
    • Provide technical input for justification in the reduction of molded part COGs.
    • Determine impact of part and process changes as they relate to Cepheid business plan.
    • Mentor other engineers in plastic injection molding and tooling, as a subject matter expert. 

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 4-5 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 preferred, in an engineering discipline.
    - Project management experience would be a plus, PMP certificate or equivalent.
    - 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.