Staff Engineer, Software V&V
Core
Define scope, design automated and manual tests, and lead a team to validate highly advanced bioinformatics software for regulated in-vitro diagnostics and medical devices.
Role type
Staff Leader in Software Verification and Validation
Builds
High quality NGS analytics and instruments software products
Domain
Life Sciences / Bioinformatics / Medical Devices
Deliverable
production ML models
Required skills
Software verification and validation testing, NGS-based regulated software, IVD assay development, informatics data analysis pipelines, software quality engineering, design control for regulated products, Agile/SCRUM methodologies, leadership of cross-functional teams
Preferred skills
Masters/PhD degree, experience leading multi-site teams, knowledge of US-IVD, IVD-D, IVD-R, China and Japan regulations, ISO 13485, IEC 62304, 21 CFR 820
Technologies
Cloud-based toolsets, big-data analytics, test APIs, user interfaces, web services, web apps
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; Drive requirements for regulated assays and software
Seniority
Staff, hands-on leader with mentorship responsibilities
