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Sr IVD Systems Engineer

Guardant Health

Sr IVD Systems Engineer

Redwood City, CA
Paid
  • Responsibilities

    Job Description

    As a Senior IVD Systems Engineer, you will work closely with R&D teams to design, define, manage, and document systems consisting of laboratory developed tests  for cancer diagnostics throughout the development lifecycle, as well as supporting FDA submissions within an IVD framework. In this role, you’ll have the opportunity to collaborate with functional leaders in software, bioinformatics, assay development, lab automation, sequencing, and cancer screening to support design, integration and documentation from sample receipt to clinical report generation.  You’ll take leadership role within the Systems engineering team to spearhead all regulatory aspects of technical projects.

    We’ll look to you to optimize and integrate 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.

    ESSENTIAL DUTIES AND RESPONSIBILITIES:

    • Lead and/or participate in system architecture and integration design, development, testing documentation and implementation.
    • Develop evaluation methods to analyze workflows, identify bottlenecks, benchmark process performance and develop solutions to improve efficiency, throughput, cost, and quality.
    • Ability to work with functional system owners to design and develop future proof, scalable and integrated systems from beginning to end of the clinical sample workflow(s)
    • Ownership and management of the system definition and architecture of all subsystem components of our laboratory developed tests.
    • Document all aspects of system design and development in accordance with design control requirements.
    • Develop and maintain requirement traceability through various subsystems and verification activities in collaboration with subsystem requirements owners
    • Contribute to data-driven decision making by designing experiments and collecting, analyzing, and presenting data results.
    • Lead and drive system risk management activities for system and subsystems  throughout the development life-cycle
    • Mentor more junior systems engineers.
    • Establish and maintain alignment across multiple teams within the company with focus on execution, continuous improvement, and operational excellence.
    •  Want to push role as a contributor to system design as well as capturing and managing the design
  • Qualifications

    Qualifications

    • B.S. or M.S. in Engineering or a Life Science with 5-10 years in Systems or Process Engineering involving software and hardware implementations for life science products, in vitro diagnostics or medical devices under design control (21 CFR Part 820, ISO 13485) in a regulated environment.
    • Understand and generate deliverables related to design controls in support of a regulated industry.
    • Background in nucleic acid based diagnostics technology and experience with next-generation sequencing are highly desirable. Other system development experience in complex clinical diagnostic development environments is a plus.
    • Excellent verbal and written communication skills.
    • Enjoy working independently and collaboratively in a fast-paced environment and able to adapt to change.
    • Experience in and success with influencing and working through others to achieve results within in a complex matrix organization.

    Additional Information

    All your information will be kept confidential according to EEO guidelines.

     

     

     

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