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Diagnostic Consumables Engineer II

Danaher
Sunnyvale, CA
24 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 :

    The Cepheid Engineering team is seeking a Diagnostic Consumables Engineer who will apply their experience with injection molded plastics to transform product requirements into sustainable, large-scale consumables production. The successful candidate must be able to use their knowledge of mechanical design, materials, automation, process development and molding to engineer custom solutions, improve current designs, interface with vendors, and enable large scale manufacturing of consumables for the medical device industry. They will actively sustain and support re-qualifications of existing parts used in Production following tooling repairs and refurbishments. This is a hands-on position involving detailed design, 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 :


    - 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.

    - Maintain and/or improve existing consumables parts production, with an emphasis on refining part specifications, improving manufacturability, and achieving cost reductions

    - Use CAD modeling, prototyping, and hands-on lab testing to develop new designs to support and enhance consumable product line.

    - Design, test, and validate new consumable designs in collaboration with diverse functional groups
    - Actively participate in group meetings and be a technical point person in project teams.
    - Use 3D CAD modeling, statistical analysis, and hands-on bench or line testing to characterize part attributes, process performance, and assembly characteristics.
    - Proactively identify risks in the design of processes, equipment, and methods associated with consumables manufacturing and design quality into the equipment or process design rather than relying on inspection to detect non- compliance.
    - Establish working relationships with vendors for outsourcing of engineering services, equipment design, and analytical testing 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.
    - Assist in failure investigations and root cause analyses as they relate to consumables part 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.
    - 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.

    -Development robust processes through the use of DOE

 

Qualifications

  • Qualifications

    Required Knowledge, Skills, and Abilities
    - BS in Engineering or equivalent combination of education and experience to perform at this level.
    - 3-5 years of related work experience
    - Excellent verbal and written communication skills.
    - Must be proficient with standard Microsoft Office applications.
    - Experience with inspection and measurement techniques
    - Working knowledge of GMP, ISO, and FDA rules and regulations
    - Experienced with creating drawings, BOMs, product specifications
    - Quality Management System experience

    - Experience with the validation of parts and processes


    Preferred Qualifications


    - Basic knowledge of FMEA and SPC
    - Basic machining skills are a plus
    - Industry experience in medical device consumables
    - Experience with plastic injection molding and part design
    - Experience in project management fundamentals
    - Quality Management System experience
    - Proficiency with SolidWorks.
    - Experience with high volume manufacturing processes, including machining, extrusion, and molding

    - Experience with failure investigations and root cause failure analysis
    - Experience with ultrasonic welding of plastics

    - Process development utilizing DOE

    Physical Demands


    - Ability to lift 10 - 20 lbs

    design information to drafting for packaging documentation. Jobs that provide engineering technical support in this field should be assigned to this job family.

 
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...