Lead Engineer, Systems Engineering & System Integration

Location
Brisbane, CA
Posted
Sep 27, 2021
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. 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 a team of scientists and engineers from diverse fields to support Mammoth’s diagnostics product portfolio from concept through development, verification and validation, design transfer and commercialization
  • Work with design engineering, manufacturing engineering, and assay scientists to define the requirements for Mammoth’s products
  • Specifically this role is envisioned to “own” the requirements for an IVD platform through development, verification, transfer to manufacturing, regulatory submission, and launch
  • Mentor earlier career scientists or engineers -- leverage your experience by coaching, training and leading others as the team develops an IVD platform 
  • 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.
  • Plan and execute the verification for each diagnostic product
  • Contribute to the risk management process for each Mammoth 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
  • 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
  • 8 years of industry experience 
  • Direct responsibility for the product requirements during successful development, verification, validation, transfer to manufacturing and launch of a regulated device.  Industries that have relevant regulatory regimes are IVD, medical device, aerospace, and automotive.
  • “Ownership” of requirements through the product development cycle -- requirements definition, traceability, verification test development, test program execution, regulatory approval, and launch.
  • Significant experience contributing  to the FMEA and risk management associated with that product
  • Experience using a statistical approach and scientific method to design and carry out experiments, including selection of sample number (N) for different types of tests/experiments at different stages in the development process

PREFERRED QUALIFICATIONS
  • MS or PhD in a relevant field of engineering, biological science, bioengineering, physics, or chemistry
  • A basic understanding of a wide range of disciplines is foundational to System Integration/ System Engineering: clinical, biochemical, molecular biology and biochemistry, engineering, physics, statistics
  • 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
  • If experience with IVD/ biochemistry / life sciences does not exist, a desire and openness to learn and collaborate
  • 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
  • Self-motivated and able to work well in a team

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.