Engineer III Software Test
Core
Lead software verification and validation for advanced bioinformatics and NGS analytics software in the regulated in-vitro diagnostics/medical device space.
Role type
Senior IC software test engineer (lead/mentor)
Builds
High quality NGS analytics and instruments software products
Domain
Biotech / Medical Devices / Bioinformatics
Deliverable
production ML models
Required skills
Software verification and validation, NGS-based regulated software, IVD assay development, informatics data analysis pipelines, leadership, design control for regulated products, Agile/SCRUM methodologies
Preferred skills
Masters/PhD, experience leading cross-functional multi-site teams, experience with US-IVD, IVD-D, IVD-R regulations
Technologies
Cloud-based toolsets, big-data analytics, web services, web apps
Responsibilities
Define scope and design automated and manual tests, drive writing smoke and regression test scripts, establish software quality standards and KPI metrics, partner with stakeholders to drive requirements for regulated assays, mentor software test engineers
