内推 system Engineer， IVD

请发简历到arthurbuffet At hotmail.com
Job description[color=rgba(0, 0, 0, 0.701961)][size=1.5]About The Role

We are looking for a team member who will lead successful delivery of world-class in vitro diagnostic (IVD) quality products for Guardant Health as we undergo an explosive growth phase. You will work closely with the R&D teams to draft initial technical requirements to meet IVD standards at project initiation and manage the transition of technical products into the IVD framework. You’ll have the opportunity to collaborate with industry and thought leaders in lab automation, sequencing, and cancer screening, and you’ll take a leadership role within the automation team to spearhead all FDA and regulatory aspects of technical projects.

We’ll look to you to optimize complex and multi-variate problems at the interface of laboratory automation, process engineering, molecular biology, regulatory and operations. You’ll influence and guide your colleagues to integrate the QSR mindset into their day-to-day and build efficient workflows that enable the team to navigate the regulatory environment while maintaining momentum.

About You

You’re committed to the development of IVD instruments that provide rapid and accurate diagnostic test results, and you’ll lead the automation aspect of the IVD product process implementation. You have a track record of partnering successfully with development teams on design and implementation of automated solutions, including collaboration with assay development and bioinformatics to generate IVD development plans for existing and future products.

You have experience performing requirements analyses and are skilled at translating customer needs into engineering requirements, driving towards the decomposition and allocation of system level requirements into subsystem level requirements. You circle back to ensure that design meets operational expectations. You see projects through to completion, providing support to product launches, troubleshooting and conducting failure analyses.

You Will

• Do hands-on software development on robotics systems and supporting software interface
• Design and establish verification protocols for system qualification of hardware and software
• Perform system modeling and analysis
• Design and perform test procedures that exercise the integration of sub-systems and the whole system, including the user interface and error handling processes
• Detail specific design integration efforts
• Write and direct the Verification Plans and Verification Procedures for hardware/firmware qualifications.
  
  
  

You Bring

• BS or MS in Engineering or a Life Science
• 5 years of experience with software and hardware design and implementation of automation for life science products, in vitro diagnostics or medical devices.
• Experience with FDA and ISO design controls
• Experience in the development of (IVD) instruments that provide rapid and accurate diagnostic test results Experience developing laboratory workflows for Next Gen Sequencing diagnostic tests.
  
  
  

About Our Company

Guardant Health develops breakthrough diagnostic technologies to improve cancer management. With Guardant360, we offer real-time, biopsy-free tumor sequencing that tracks tumor genomics in real-time and identifies associated treatment options. The recent introduction of groundbreaking analytical tools, including our Tumor Response Map and a mobile-enabled physician portal, further advance Guardant Health's momentum. Guardant Health has raised more than $200M in capital from Sequoia Capital, Khosla Ventures, Lightspeed Ventures, OrbiMed Capital and other well-known investors, and is led by a seasoned management team of thought leaders and successful serial entrepreneurs in next generation sequencing and rare cell diagnostics. They are advised by an oncologist-led medical steering committee from leading cancer centers.

给楼主寄信了
art.xx.xang@gmail.com

感谢楼主

请问楼主现在还在招人嘛？