Sr. Bioinformatics Quality/Test Engineer
Core
Leading testing efforts for all software components of an end-to-end clinical assay, ensuring robust scrum and release processes for medical devices and LDT products.
Role type
Senior Quality/Test Engineer (Software)
Builds
End-to-end clinical assays, medical device software, and LDT products
Domain
Healthcare / Bioinformatics / Medical Devices
Deliverable
production ML models | product features
Required skills
Verification and validation protocols, hazard analysis, risk assessment, design controls, audit material creation, system end-to-end testing, integration testing, programming/scripting (Python, Ruby, Java, etc.), database testing, Agile/Scrum lifecycle management
Preferred skills
Automated software testing (unit, integration, system), container orchestration (Docker, Kubernetes), cloud platforms (AWS, GCP, Azure), bioinformatics analysis pipeline frameworks, FDA-regulated medical device experience, cybersecurity risk management, requirements management tools (JAMA, DOORS)
Technologies
Jenkins, GitLab, Postman, SOAPUI, JMeter, Selenium, TestNG, Docker, Kubernetes, AWS, GCP, Azure, Python, Ruby, Perl, Groovy, Java, JavaScript
Responsibilities
Develop and execute verification and validation protocols, translate requirements into executable protocols, create and manage design control documentation, participate in risk assessments, mentor team members on software quality processes, represent software activities in audits
Seniority
Senior, hands-on IC with mentorship responsibilities