Systems Integration Lead

San Francisco /
Diagnostics /
Full-Time
COMPANY
Mammoth Biosciences is harnessing the diversity of nature to power the next generation of CRISPR products. Through the discovery and development of novel CRISPR systems, the company is enabling the full potential of its platform to read and write the code of life. Mammoth aims to democratize disease detection with an easy and affordable point-of-care test that allows real-time and simultaneous detection of multiple conditions. By leveraging its internal research and development and exclusive licensing to Cas12, Cas13 and Cas14, Mammoth can provide enhanced diagnostics and genome editing for life science research, healthcare, agriculture, biodefense and more. Based in San Francisco, Mammoth Biosciences is co-founded by CRISPR pioneer Jennifer Doudna and principal founders Trevor Martin, Janice Chen, and Lucas Harrington. The firm is backed by top institutional investors including Mayfield, NFX, and 8VC, Decheng, and leading individual investors including Brook Byers, Tim Cook, and Jeff Huber.

OPPORTUNITY
Mammoth is looking for a Systems Engineering and Integration team leader. This position is critical to Mammoth’s charter of using innovative CRISPR enzymes in diagnostic products. The Systems Engineering and Integration team will be the technical hub for integrating the chemistries, mechanics, electronics and control systems to commercially launch the future of molecular diagnostics.

KEY RESPONSIBILITIES

    • Organize a team of scientists and engineers from diverse fields to support Mammoth’s diagnostics product portfolio from concept through, verification and validation, design transfer and commercialization
    • Recruit and hire Systems Team members that share the vision for this team as the technical conscience and hub of the product’s various technologies
    • Lead the Systems Team to work with design engineering, manufacturing engineering, and assay scientists to define the requirements for Mammoth’s products
    • Lead the risk management process for each Mammoth diagnostic product
    • Utilize the technical skills and experiences of the Systems Team members to assist and facilitate the designing of reagents and devices that will meet the defined requirements
    • Lead the systems team to execute a successful integration of the assay reagents with the device’s components
    • Use frequent and early confidence building testing to provide early feedback to the design engineers and assay scientists that design paths are valid.  Effectively use this data to influence corrections in the design process when data indicates it is necessary
    • Lead the execution of each diagnostic product’s verification phase
    • Be a key leader and resource that supports the validation of the diagnostic products
    • The Systems Team will be a key participant in the design transfer to manufacturing process. The person in this role will organize the Systems Team to support manufacturing engineering in assembly work instruction development, test method development and manufacturing validation activities
    • The Systems Team will be the primary technical interface for the customer support teams as they learn about the diagnostic products
    • Be one of the champions of integrating and applying a useful and value added QMS and work with the QA teams to improve the QMS when necessary
    • Write plans, protocols and reports that are compliant with 21 CFR 820 and ISO 13485

REQUIRED QUALIFICATIONS

    • A minimum of 10 years working in the medical device or IVD industry within a 21 CFR 820 quality management system
    • A Systems Engineering or Systems Integration team leadership role working on a medical device or IVD product
    • Part of a team that has commercialized a medical device or IVD product
    • Experience of successfully leading teams of 8 to 15 people
    • BS in engineering, biological science, physics or chemistry

PREFERRED QUALIFICATIONS

    • 4 or more years of experience of working in product development in a Systems Engineering or Systems Integration role
    • Expansive participation in the development of at least one product that has successfully completed a majority of the product development phases of Concept and Feasibility,  Design, Verification, Validation, Design Transfer, Product Launch, Product Support

BENEFITS

    • Competitive salary with equity
    • Company-paid health/vision/dental benefits
    • Unlimited vacation and generous sick time
    • Free breakfast/lunch/dinner/barista
    • Free gym
    • Public transportation commuter subsidy
    • 401(k) matching