Associate Director, Software Engineering

Location
Brisbane, CA
Posted
Oct 07, 2021
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time
OPPORTUNITY
Mammoth is looking for an experienced Associate Director, Software Engineering that will build and lead a team of 3 to 5 persons and a significantly sized software development effort via external contractors and consultants. The Associate Director will lead both the embedded software development efforts and the development of the GUI and data interface software. This leadership position is critical to Mammoth’s charter of using innovative CRISPR enzymes in diagnostic products. The Software Engineering team will lead the embedded, GUI and data I/O development efforts. The embedded and interface software must comply with US FDA and international requirements for in-vitro diagnostics (IVD) development.

The embedded real-time operating system (RTOS) and multi-tasking software development efforts will work with Mammoth’s mechanical, electrical and systems engineering teams to control thermal and fluidic actuators and receive data from sensors required to execute the CRISPR based molecular diagnostic assays.  

The interface software team will have two responsibilities: Development of a GUI that will be capable of obtaining IVD CLIA waiver; and development and management of an external data transfer I/O system via Bluetooth and/or Wifi. Cybersecurity management will be a responsibility of this leader.

The Associate Director and the software team will interface with the Mammoth QA team to ensure compliance with Mammoth’s quality management system. 
KEY RESPONSIBILITIES
  • Work with a team of scientists and engineers from diverse fields to design and support Mammoth’s diagnostics product portfolio from concept and design through verification and validation, design transfer and commercialization 
  • Manage a team of 3 to 5 Mammoth employees dedicated to embedded software, GUI, and data transmission to and from healthcare provider’s LIM systems 
  • Select and manage contracted software development consultants to augment the internal software development team’s capabilities and capacity
  • Select and maintain embedded operating system
  • Detailed knowledge of the applicable FDA expectations and requirements for software development from requirements to releases including software validation, off-the-shelf software, SOUP and cybersecurity

REQUIRED QUALIFICATIONS
  • A minimum of 10 years post-academic software development experience with at least 5 years working on a medical device or IVD within a 21 CFR 820 quality management system
  • Bachelor of Science degree in software or computer engineering
  • Experience working on products that have been commercialized or will be commercialized within 3 years
  • Experience working on an FDA regulated medical or IVD product

PREFERRED QUALIFICATIONS
  • Experience with a PMA or 510(k) submission and approval or clearance
  • Experience with an FDA software review and audit

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

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.