Adela is focused on the detection of cancer and other high-morbidity, high-mortality conditions through a blood test. The Company’s genome-wide methylation analysis technology has the unique ability to distinguish the most highly informative (methylated) regions of the genome from the non-informative regions and preferentially target those informative regions for sequencing. The technology is initially being developed for use across the cancer continuum for detection, diagnosis and management and in the future will be applied to other conditions beyond cancer.

Summary:

The Director of Software Engineering will be responsible for supporting and building a team to develop medical device software in accordance with regulatory requirements in an early start up environment from the group up without minimal established processes. This position will develop and define the software development lifecycle for building medical device software for Adela’s proprietary early cancer detection assay.


Responsibilities:

  • Develop and build teams to drive key activities related to software development and data strategies.
  • Implement automation for Bioinformatic pipeline build, test and deployment
  • Execute software tests and validation activities, automating evidence generation for PMA, 510(k), CLIA, and other regulatory submissions
  • Develop strategies for provision and recording of objective evidence supporting verification and validation
  • Select technologies, methodologies, and approaches:

· for high quality test construction and execution

· to support software systems engineering, including configuration management, build automation, requirements management tools, etc.

· for automated deployments and software IQ/OQ/PQ

  • Implement systems engineering and design controls including authoring of SOP and work instructions.
  • Ensure that test strategies and practices integrate with development and deployment efforts
  • Collaborate with R&D to establish appropriate test baselines, acceptance criteria, software architecture and datasets
  • Collaborate with quality/regulatory teams to ensure that test and automation meets key regulatory needs for Medical
  • Device and Lab Developed Test (LDT)
  • Collaborate with sales/business development teams to continuously improve product definitions and product delivery to develop new clients and retain existing ones.
  • Collaborate with program and project management teams.
  • Build safety and cybersecurity risk management processes
  • Manage team’s resources include people, processes, and software tools.
  • Negotiate or approve contracts for teams relevant to software V&V, automation, etc.
  • Create and implement strategies to utilize engineering strategy to build business growth.
  • Ensure that the team delivers quality products.
  • Improve internal processes for better productivity.
  • Oversee and be accountable for large projects.
  • Manage budgets and the financial health of team.


Requirements:


  • Bachelor’s in any STEM degree; Computer Science degree is a plus.
  • Significant understanding of software lifecycle development and history of executing software development programs under ISO 62304.
  • Familiar with FDA regulatory requirements for medical device software. (Other regions are a plus, Japan, Europe (etc).
  • Experience overseeing a successful medical device submission (either an approval or a deficiency letter with no major findings for the software components).
  • Understanding of the discipline of Systems Engineering and an appreciation for its importance for medical devices.
  • Strong history of releasing both regulated and unregulated commercial software in the NGS diagnostic space.
  • Management experience overseeing software engineering teams and systems engineering teams for medical device software submissions.
  • A philosophy of prioritizing automation in order to support scaling and improving time to market.
  • Experience architecting build and testing systems.
  • A passion, vision and clear philosophy on how to approach building medical device software in the NGS diagnostic space.