Senior Systems Integration Engineer (Multiple Openings)

OPPORTUNITY
Mammoth is looking for a Senior 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
• 6 to 10 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 -- preference for 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

Mammoth Biosciences is harnessing the diversity of life to power the next generation of CRISPR products. Through the discovery and engineering 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 develop permanent genetic cures through best-in-class in vivo and ex vivo therapies and to democratize disease detection with on-demand diagnostics. Mammoth can provide enhanced diagnostics and genome editing for 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 Laureate Jennifer Doudna and Trevor Martin, Janice Chen, and Lucas Harrington. The firm is backed by top institutional investors including Redmile Group, Foresite Capital, Senator Investment Group, Sixth Street, Decheng, Mayfield, NFX, and 8VC, along with leading individual investors including Brook Byers, Tim Cook, and Jeff Huber.

TEAM
The Diagnostics team is advancing our CRISPR-based DETECTR™ platform to address unmet needs across the continuum of testing. From laboratories to the home, our mission is to democratize diagnostics with CRISPR.

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.