Systems Integration Engineer

Location
Brisbane, CA, United States
Posted
Jul 02, 2021
Ref
1970993668
Hotbed
Biotech Bay
Required Education
Bachelors Degree
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 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 is advancing disease detection and treatment using its novel CRISPR systems that can deliver on the promise of precision medicine across diagnostics and therapeutics. Furthermore, Mammoth's CRISPR technology platform will enable new solutions in life science research, healthcare, agriculture, biodefense and more.

Based in the San Francisco Bay Area, Mammoth Biosciences is co-founded by CRISPR pioneer and Nobel Prize winner 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 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
    • 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 a 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, bioengineering, physics, chemistry or biological science
    • A minimum of 4 years working on products related to the life science, medical device or IVD industry
    • Participation in the development of at least one regulated IVD or medical device 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
    • Experience implementing and debugging an assays or life science workflow on at least one platform

 


PREFERRED QUALIFICATIONS

 

 

    • MS or PhD in a relevant field of engineering, biological science, bioengineering, physics, or chemistry
    • Experience implementing and troubleshooting IVD assays on one of the typical application scales: point of care/point of need, small lab or high throughput/core lab
    • Systems work requires a broad background in engineering and life sciences -- so we prefer candidates with a basic understanding of a wide range of disciplines: clinical, biochemical, molecular biology, thermal, mechanical, material, readout/detection. Additionally, deep experience in one or more areas is nice to have
    • Significant experience working in product development on a commercially impactful diagnostic or life sciences product
    • Familiarity with a quality management system that supports medical device products and certifications -- 21 CFR 820 or CE mark
    • Experimental design and statistics of experimental design
    • 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

 


BENEFITS

 

 

    • Company-paid health/vision/dental benefits
    • Unlimited vacation and generous sick time
    • Company-sponsored meals and snacks
    • Wellness, caregiver and ergonomic 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.