Systems Integration Engineer

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. By leveraging its internal research and development and exclusive licensing to patents related to Cas12, Cas13, Cas14 and CasPhi, Mammoth Biosciences can provide enhanced diagnostics and genome editing for life science research, healthcare, agriculture, biodefense and more. Mammoth is democratizing disease detection with easy and affordable point-of-care tests that allow real-time and simultaneous detection of multiple conditions, along with high-throughput tests that allow for unprecedented testing volume. Further, the company is transforming disease treatment with its proprietary micro-sized CRISPR proteins that enable new editing and delivery options. 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 Decheng, Mayfield, NFX, and 8VC, and leading individual investors including Brook Byers, Tim Cook, Bob Nelsen, and Jeff Huber.

OPPORTUNITY

Mammoth is looking for Systems Engineering and Integration professionals that will execute on a team of 5 to 9 persons. These positions are 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

• Work on 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.

As a member of the Systems Team:

• Work with design engineering, manufacturing engineering, and assay scientists to define the requirements for Mammoth's products.
• Execute the risk management process for each Mammoth diagnostic product.
• Assist and facilitate effective and efficient desig of reagents and devices that will meet the defined requirements.
• Execute a successful integration of the assay reagents with the device's components.
• Conduct 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.
• Execute the verification for each diagnostic product.
• Be a key resource that supports the validation of the diagnostic products.
• Participate in the design transfer to manufacturing by supporting 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 a champion for 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 3 years working in the medical device or IVD industry within a 21 CFR 820 quality management system
• Experience in working on products that have been commercialized or will be commercialized within 3 years
• BS in engineering, a 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