Engineer III, Software Test
Core
Define scope, design, and lead automated and manual testing strategies for advanced bioinformatics software in the regulated in-vitro diagnostics/medical device space.
Role type
Senior IC software verification and validation engineer (team lead)
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, leadership, design control for regulated products, Agile/SCRUM methodologies
Preferred skills
Masters/PhD, experience leading cross-functional multi-site teams, knowledge of US-IVD/China/Japan regulations
Technologies
None explicitly stated
Responsibilities
Develop and implement software testing strategy, methods, and best practices; Lead and mentor a group of bioinformatics and software test engineers; Establish software quality standards and KPI metrics; Act as single point of contact for external partners; Partner with leadership to identify testing scope and manage overall testing activities; Partner with stakeholders to drive requirements for regulated assays and software.
Seniority
Senior, hands-on IC with leadership responsibilities
