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Diagnostic Consumables Engineer II

Danaher
Sunnyvale, CA
29 days ago: Danaher

Job Description

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

  • Overview:

    As a Diagnostic Consumables Engineer, you will be a part of a fast-pace, multi-disciplinary, and creative team that drives product development activities and implements continuous improvements to new and existing processes. The ability to help develop products, trouble-shoot, define root cause, provide resolution, and implement the necessary changes efficiently in an FDA regulated environment is critical. The ability to identify problems and create solutions through research and solid technical principles/disciplines is necessary. This is a hands-on position involving mechanical design, laboratory testing, engineering studies, data analysis, and Engineering support of Production; a successful candidate must demonstrate initiative and interface well with cross-functional teams of engineers, scientists, and operations personnel.

    Responsibilities:

    • This position entails a high level of organization, excellent communication skills, and rigorous process discipline and documentation to assure functionality, safety, reliability and quality of the product.
    • In support of New Product Introduction (NPI) efforts, use knowledge of mechanical design and material science for hands-on lab testing to develop and enhance part attributes; work with design engineers to optimize design drawings and supplier manufacturing processes so that high quality parts are consistently delivered.
    • Design, test, and validate new consumable designs in collaboration with diverse functional groups from initial design to market and manufacturing release.
    • Hands on experience with validations, design for manufacturing (DFM), material selection, CAD modeling, prototyping, and process development.
    • Conduct feasibility studies of the design to determine ability to function as intended.
    • Coordinate and drive new and existing consumable part and process qualifications from inception through completion in accordance with FDA and ISO guidelines.
    • Maintain detailed documentation throughout all phases of development through manufacturing.
    • Develop and document business practices, processes, protocols, and work instructions.
    • Determine and execute the most appropriate testing to address process and system level performance issues involving cartridge consumables.
    • Assist in Problem Solving, Failure Analysis, and Corrective and Preventative Actions with suppliers.
    • Promote a culture of structured problem solving.
 

Qualifications

  • Qualifications:

    A qualified candidate must:

    • Have a Bachelor's degree in Engineering plus 3-5 years of related work experience with a good understanding of specified functional area or equivalent combination of education and experience to perform at this level.
    • Be an independent worker requiring minimal supervision. Follow established procedures; work will be reviewed for soundness of technical judgment, overall adequacy and accuracy.
    • Be willing to learn new methods and tools to analyze functional assay performance of product and investigate failures.
    • Have solid mathematical skills with basic statistics knowledge.
    • Be able to communicate verbally in an efficient and effective manner and be proficient in document preparation and editing, including detailed test plans and report writing.
    • Be able to analyze data, synthesize conclusions, and present coherent form for clear presentation.
    • Have experience with creating BOMs and product specifications.
    • Have print reading experience.
    • Demonstrate ability to understand and comply with applicable GMP, ISO, and FDA regulations and Company operating procedures, processes and policies.

    Preferred Qualifications:

    • Experience with high volume manufacturing processes, including machining, extrusion, molding, ultrasonic welding.
    • Experience with creating drawings, GD&T (Geometric Dimensioning and Tolerancing), quality measurement technique, and use of SolidWorks.
    • Proficiency with data analysis software such as Matlab, R, Minitab, or Excel in order to conduct statistical analyses on collected data.
    • Working knowledge of design of experiments (DOE), Failure Mode Effects Analysis (FMEA), Statistical Process Control (SPC) and interpretation of test results is highly desirable.
    • Strong analytical and troubleshooting skills to understand system interfaces and be able to quickly analyze, troubleshoot, and resolve system interoperability problems is highly desirable.
    • Experience with failure investigations and root cause failure analysis.
    • Experience working with biological samples in a medical device development environment.
    • Working knowledge of Polymerase Chain Reaction (PCR) or other biological applications of fluorescence-based techniques.
    • Experience with data-driven problem-solving methodologies (e.g. DMAIC).

    Physical Demands:

    Ability to lift 10 to 20 lbs.

 
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.
 

Job Function

:     Engineering

  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...