Engineer II Software Test
Core
Define scope, design, and drive strategies for automated and manual tests for highly advanced bioinformatics software in the regulated in-vitro diagnostics/medical device space.
Role type
Senior IC software test engineer (verification and validation)
Builds
High quality NGS analytics and instruments software products
Domain
Biotech / Medical Devices / Regulated Software
Deliverable
production ML models
Required skills
Software verification and validation, NGS-based regulated software, IVD assay development, informatics data analysis pipelines, design control for regulated products, Agile/SCRUM methodologies, performance/load/stress testing, API and web service testing
Preferred skills
Masters/PhD, leadership in software development methodologies, experience with US-IVD, IVD-D, IVD-R regulations, ISO 13485, IEC 62304, 21 CFR 820
Technologies
Cloud-based toolsets, big-data analytics, web services, web apps
Responsibilities
Develop and implement software testing Strategy, Methods and Best Practices; Drive writing positive and negative smoke and regression test scripts; Partner with software and bioinformatics leadership to identify appropriate scope of software testing; Work with Leads to implement software quality tracking tools and methodologies; Effectively work with external partners to deliver state of the art Software products
Seniority
Senior, hands-on IC with leadership responsibilities
