This role works out of our Headquarters in Redwood City, CA. Due to the Covid 19 Pandemic Guardant Health has temporarily classified this role as ‘partial working from home status’, meaning as duties apply this role the person will be expected onsite a few days a week.
We will fully return onsite at HQ when it is determined safe to do so.
Guardant Health is a leading precision oncology company focused on helping conquer cancer globally through use of its proprietary blood tests, vast data sets and advanced analytics. The Guardant Health Oncology Platform is designed to leverage our capabilities in technology, clinical development, regulatory and reimbursement to drive commercial adoption, improve patient clinical outcomes and lower healthcare costs.
In pursuit of our goal to manage cancer across all stages of the disease, Guardant Health has launched two liquid biopsy-based tests, Guardant360 and GuardantOMNI, for advanced stage cancer patients, and is developing programs for recurrence and early detection, called Project LUNAR. Since its launch in 2014, Guardant360 has been used by more than 5,000 oncologists, over 40 biopharmaceutical companies and all 27 of the National Comprehensive Cancer Network centers.
To enable Guardant Health to lead the disruption of cancer treatments through non-invasive cancer screening, the Technology Development team is seeking a highly motivated, Systems Engineer to design, implement, and validate new technologies related to liquid biopsy sequencing assays for the early detection, treatment, and monitoring of all cancer types. At Guardant, we leverage the most advanced technologies and work with leaders in many different fields to create the most impactful, meaningful, and scaleable technologies for cancer management.
In this role, you’ll be part of a systems engineering team which documents and manages technical requirements, specifications and performs verifications of assay automation equipment workflows. These workflows combine with other subsystems to meet system level requirements for Guardant IVD tests under a QSR environment.
You will also have opportunities to support automation development and process engineering projects, to collaborate with internal and external colleagues and customers from diverse scientific, engineering, operational, and regulatory disciplines on cross functional teams. These cross functional teams will explore, develop, optimize, test, and implement robust, scalable solutions for Guardant Health’s sample processing workflows with attention to understanding business and user requirements and improving efficiency, throughput, and quality.
You will be expected, after training, to understand, and to perform all laboratory procedures needed to process samples with our workflows to support process development and implementation activities.
Essential Duties and Responsibilities:
- Interface between stakeholders to gather, manage and document technical subsystem level requirements.
- Write specifications, and develop test procedures to verify assay automation equipment workflows.
- Execute detailed verification test protocols and create verification reports.
- Review and author documentation per QSR and CLIA regulatory standards.
- Perform tech transfer activities and support sustaining operations as needed.
- Develop design templates for multiple projects and implement standardized processes.
- Establish and maintain alignment across multiple teams within the company with focus on execution, continuous improvement, and operational excellence.
- Develop evaluation methods to analyze workflows, identify bottlenecks, benchmark process performance and develop solutions to improve efficiency, throughput, cost, and quality.
- Contribute to innovation of current and new assay workflows, technologies and processes, which include automation development of hardware, instrument control, applications, consumables, and assay processing.
- Partake in design reviews, risk analysis, troubleshooting, production activities and other project tasks as needed.
BS degree in engineering or science or a closely-related discipline with 3-5 years of related industry experience
Minimum 3-year experience in Systems Engineering,
Experience working within Windows OS, Mac OSX, and Linux in a mixed enterprise environment.
Experience with troubleshooting technical computer hardware, software, and networking problems.
Experience with operating and programming liquid handling robotics platforms (Hamilton, TECAN, Beckman, Agilent) is a plus.
Experience with standard molecular biology techniques such as nucleic acid isolation, purification, quantitation, bioanalyzer, DNA/RNA quantitation, qPCR, or next-generation sequencing is a plus
Experience with statistical analysis and quality tools (Fishbone Diagrams, Control Charts, Pareto Analysis, etc.).
Familiarity with the Software Development Lifecycle concepts, configuration management, source code control, and deployment strategies in a production environment.
Strong Documentation skills.
Experience writing user requirements, functional specifications, validation plans, and other technical guidelines regarding hardware or software configuration.
Experience creating process flow diagrams.
All your information will be kept confidential according to EEO guidelines.
Employee may be required to lift routine office supplies up to 20 lbs and use office equipment. Majority of the work is performed in a desk/office environment; however, there may be exposed to high noise levels, fumes, and biohazard material in the laboratory environment. Ability to sit for extended periods of time.
Guardant Health is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
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