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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.
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.
