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 Bioinformatics Engineer will lead our medical device software development effort for Adela’s proprietary cfMeDIP NGS assay. The assay pulls down from cell-free DNA methylated regions of the human genome using immunoprecipitation. This role will be responsible for working closely with a cross functional team to commercialize a diagnostic bioinformatics pipeline for PMA, 510(k), CLIA, and other regulatory submissions. The Bioinformatics Engineer will also work to establish and execute the methodology for medical device software development in an early start-up environment.
Responsibilities
- Architect and engineer bioinformatics pipelines that will be part of a medical device
- Build software within the regulatory framework using SDLC principles for medical devices
- Help establish and define methodologies for medical device software development in an early start-up environment
- Develop pipelines to be platform agnostic in a cloud first engineering organization
- Automate verifications and compliance activities
- Educate junior developers in the methodologies used for medical devices
Education and Requirements
- Degree in Computer Science or relevant field. Experience with writing software in highly regulated industries.
- 5 years minimum experience
- Experience writing software in highly regulated industries. experience with NGS diagnostics applications is a plus
- An understanding of NGS diagnostics assays and common engineering challenges that arise in the space, this can be substituted with experience in writing software in highly regulated industries that have high compute and data requirements
- Hold patient safety and regulatory compliance as a top priority
- Experience working on a team with a successful regulatory submission and the subsequent post market maintenance of the medical device software is a plus
- A philosophy of prioritizing the automation of redundant and tedious compliance tasks in order to support scaling and efficiency
- An insatiable curiosity and healthy dose of skepticism that drives critical thinking
- A trailblazer that is not afraid to navigate a start-up environment with few well-established processes