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  • Sunnyvale, CA

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Mechanical Engineer

Cepheid • Sunnyvale, CA

Posted 2 months ago

Job Snapshot

Full-Time
Experience - 5 years
Degree - 4 Year Degree
Medical Equipment, Biotechnology, Manufacturing
Engineering

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).

Responsibilities:

  • Responsible for the mechanical design and development of automation projects including design requirements, test plans, prototype material procurement, assembly, testing and final production release
  • Contribute to the definition and design of the system architecture, ranging from simplified block diagrams, to the detailed architecture
  • Create documentation including, but not limited to, design input requirements, specifications, design of experiments, assembly and service procedures
  • Author acceptance test and validation protocols and reports
  • Lead own design reviews for all phases of the design process
  • Selection and specification of machine components such as motors, pneumatics, solenoids, conveyors, part feeding components and hardware
  • Ability to perform engineering calculations such as force, speed, stress & thermal analysis, etc. as relevant to the application
  • Modify existing equipment to improve product quality, increase part throughput, decrease cost, and/or strengthen safety measures
  • Perform change orders and release processes using Agile
  • Maintain strict compliance with ISO13485, cGMP, QSR and other applicable Quality Management System standards
  • 10% Travel

Job Requirements

Minimum Requirements:

  • Bachelor’s degree in Mechanical Engineering with 5 - 7 years of related work experience, OR
  • Master’s degree in Mechanical Engineering with 3 - 5 years of related work experience
  • Minimum 2 years of mechanical design experience including, but not limited to, high speed assembly tools, precision mechanism, robotics and automation
  • Hands on experience with electro-mechanical troubleshooting in a high-volume automated manufacturing environment
  • Excellent oral and written communication skills
  • Proven project management skills
  • Strong analytical and problem-solving skills combined with a strong technical presence
  • Proficient in MS Office Suite (MS Word, Excel, PowerPoint)
  • Proficient in SolidWorks 2012 or later, PDM or EPDM preferred
  • Proficient with ANSI Y14.5-2009 and use of GD&T\
 

Preferred Requirements:

  • Experience in the Medical Device field and Quality regulations environment
  • Experience using Agile
  • Experience writing IQ, OQ, and PQ Protocols
  • Conceptual understanding of injection-molded plastic parts

Job ID: CEP002877
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