Director, Systems Engineering and Integration

Location
Brisbane, CA
Posted
Jun 13, 2022
Hotbed
Biotech Bay
Required Education
Doctorate/PHD/MD
Position Type
Full time
OPPORTUNITY
Mammoth is looking for a passionate and experienced Systems Engineering and Integration professional to lead these two disciplines. 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
  • Work with Mammoth leadership from diverse fields in areas of manufacturing, commercialization as well as engineering and assay development to develop  Mammoth’s diagnostics product portfolio from concept through verification and validation (v&v), design transfer and commercialization
  • Lead the Systems Engineering discipline at Mammoth in requirements management, risk management, V&V execution and design outputs to inputs traceability analysis
  • Lead the Systems Integration discipline at Mammoth to specialize in hands-on testing and intense understanding of operation of integrated design subsystems across interfaces in software, hardware and reagent sub-systems
  • Lead the Systems Engineering and Integration Teams in developing capabilities to model and execute predictive simulations of a product’s future reliability and performance
  • Lead the Systems Engineering and Integration Teams to generate data to confirm that expected performance and reliability expectations are being met

REQUIRED QUALIFICATIONS
  • BS in engineering, biological or physical sciences
  • A minimum of 15 years of experience developing a medical product or IVD products including at least 7 years working within and leading Systems Engineering and/or Systems Integrations teams
  • Experience mentoring and leading teams of technical contributors

PREFERRED QUALIFICATIONS
  • MS or PhD in engineering, biological science, bioengineering, physics, or chemistry
  • Knowledge of a wide range of disciplines is foundational to System Integration/ System Engineering, so knowledge in clinical, biochemical, molecular biology and biochemistry, engineering, physics, statistics, use of computers and other analytic methods to solve problems in medical device/IVD development
  • Basic molecular biology wet lab experience - including methods such as- sample extraction, DNA manipulation, PCR, qPCR, nucleic acid purification or sample extraction, CRISPR
  • 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
  • Specific experience in any of the steps/technologies associated with implementing an IVD/molecular diagnostic assay or CRISPR workflow: thermal control of fluids, mixing, nucleic acid purification, nucleic acid amplification, readout/detection of assay, shelf storage of chemistry, reagent mixing and utilization, sample lysis/prep
  • Familiarity with a quality management system or that supports medical device products and certifications -- 21 CFR 820 or CE mark or similar regulatory environments in automotive or aerospace

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.

Mammoth Biosciences requires that all employees be vaccinated against COVID-19 as a condition of at-will employment, with exceptions for medical or religious reasons in compliance with local, state, and federal law.