Systems Integration Engineer

Location
Brisbane, CA, United States
Posted
Apr 15, 2021
Ref
533696255
Hotbed
Biotech Bay
Required Education
Other
Position Type
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 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 Brisbane, CA, 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 professional. 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 design 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
    • BS in engineering, a biological science, physics or chemistry
    • A minimum of 3 years working in the medical device or IVD industry
    • Experience in working on products that have been commercialized or will be commercialized within 3 years
    • Experience implementing and debugging fluidic protocols on an automated high throughput (robotic) fluid transfer system
    • Basic familiarity with molecular diagnostics assays and lab practices
    • Basic understanding of the steps involved in a molecular IVD assay -- sample acquisition, sample prep, amplification, readout


PREFERRED QUALIFICATIONS
    • 5 or more years of experience of working in product development in a Systems Engineering or Systems Integration role
    • Experience implementing and troubleshooting IVD assays on a high throughput platform like the Hamilton STAR or Agilent BRAVO,
    • especially script/protocol requirements development, authoring, debugging, verification
    • Experience integrating other instruments with that platform -- plate readers, sealers, barcode readers, mixers/shakers
    • Familiarity with a quality management system that supports medical device products and certifications -- 21 CFR 820 or CE mark
    • Ability to use scripting or coding languages to control laboratory equipment
    • Familiarity with the capabilities and challenges involved in an automated pipetting system
    • Experimental design and statistics of experimental design
    • 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
    • Company-paid health/vision/dental benefits
    • Unlimited vacation and generous sick time
    • Company-sponsored meals and snacks
    • Wellness, caregiver and ergonomics benefits
    • 401(k) with company matching


It is our policy and intent to provide equal opportunity to all persons without regard to race, color, religion, political affiliation, sex/gender (including gender expression/identity, pregnancy, childbirth and related medical conditions), marital status, registered domestic partner status, sexual orientation, age, ancestry, national origin, veteran status, disability, medical condition, genetic characteristics, and/or any other basis protected by law. This policy covers all facets of employment including, but not limited to: recruitment, selection, placement, promotions, transfers, demotions, terminations, training, and compensation.