GRAIL is a healthcare company whose mission is to detect cancer early, when it can be cured. GRAIL is focused on alleviating the global burden of cancer by developing pioneering technology to detect and identify multiple deadly cancer types early. The company is using the power of next-generation sequencing, population-scale clinical studies, and state-of-the-art computer science and data science to enhance the scientific understanding of cancer biology, and to develop its multi-cancer early detection blood test. GRAIL is headquartered in Menlo Park, CA with locations in Washington, D.C., North Carolina, and the United Kingdom. GRAIL, LLC is a wholly-owned subsidiary of Illumina, Inc. (NASDAQ:ILMN). For more information, please visit www.grail.com
Grail is seeking an experienced Staff Systems Engineer to join the R&D Bioinformatics team. This role will focus on execution of product development deliverables, design controls, requirements management, and general systems engineering activities as part of the development of cancer diagnostic products. You will be an embedded member of the teams that plan product development activities, develop bioinformatics pipelines, and support operations activities for on-market products. Although location in the San Francisco Bay Area is preferred, this position can be remote.
As a bioinformatics system engineer, you will be on the forefront of pioneering multiple new diagnostic products on the path to improving patient outcomes.You will:
Your background should include:
- Execute and promote good systems engineering values.
- Learn and understand the applicable technology and engage in technical discussions.
- Coordinate across multi-disciplinary teams to translate user needs, program schedules, and research milestones into software system requirements and deliverables.
- Contribute to product planning by developing software architecture, documentation, and testing strategies. Support activities of regulatory submission, including creation, review, and management of technical documents.
- Work with subject matter experts to drive execution of project risk management activities in compliance with the risk management process and industry best practices (FMEAs, Hazard Analysis, etc).
- Work with the technical writers, quality, and regulatory to write formal, detailed software development plans, software requirements specifications, hazard analysis, and external-facing software documentation.
- Guide a team of subject-matter-experts through development processes required to bring science into a regulated product.
- Engineering, Computer Science, Bioinformatics or related master’s degree with 5+ years of experience or Ph.D. with 3 years of experience bringing regulated software products to market.
- Strong experience documenting software requirements, following and shaping software development life cycles, and guiding teams in Agile development processExperience with product development in medical diagnostics, IVD regulated space.
- Experience with risk management activities and analysis techniques (FMEA, FTA, hazard analysis).
- Solid knowledge of regulatory standards such as ISO13485, ISO 14971, 21 CFR Part 11 and AAMI standards applicable to medical devices.
- Experience creating, reviewing and updating technical design documentation in a regulated environment.
- Demonstrated ability to understand and communicate technical information.
- Strong interpersonal and organizational skills.
- Experience developing or working with NGS bioinformatics software and knowledge of ML practices strongly preferred.
GRAIL is an Equal Employment Office and Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status. We will reasonably accommodate all individuals with disabilities so that they can participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us
to request accommodation.
Following extensive monitoring, consideration of business implications, and advice from internal and external experts, GRAIL US has made the decision to require that all U.S. employees be “Fully Vaccinated” with the COVID-19 vaccine and “Up to Date” with any recommended booster. “Fully Vaccinated” is defined as two weeks after both doses of a two-dose vaccine (e.g. Pfizer or Moderna) or two weeks since a single-dose vaccine (e.g. Johnson & Johnson) has been administered; "Up to Date" means having timely received any COVID-19 vaccine booster(s) in accordance with CDC guidelines. Absent a qualifying exemption, all GRAIL US employees are to comply with this requirement, including providing documentation of such vaccination status, as a condition of employment. Anyone unable to be vaccinated, either because of a sincerely held religious belief or a medical condition or disability that prevents them from being vaccinated, can request a reasonable accommodation for consideration by GRAIL.