Engineer II Software Test
Thermo Fisher Scientific11 hours ago
Bengaluru, IndiaMid Level / Senior
Responsibilities
- Develop and implement software testing strategies, methods, and best practices for regulated NGS analytics and instrument software.
- Design and execute automated and manual verification and validation tests, including smoke, regression, API, UI, web-service, performance, load, and stress testing.
- Establish software quality standards and KPI metrics and provide visibility into product quality during development.
- Coordinate testing scope and activities with software, bioinformatics, functional, and project leadership.
- Partner with internal and external stakeholders to define requirements for regulated assays and software.
- Help development teams understand complex informatics and visualization requirements for implementation.
Requirements
- Bachelor’s degree with 4–6 years of work experience, or a preferred Master’s or PhD, with a strong record of industry productivity.
- At least 4 years of experience performing software verification and validation testing, preferably in medical-device or biotechnology environments.
- Strong understanding of NGS-based regulated software, IVD assay development practices, and informatics data-analysis pipelines.
- Experience leading modern software-development methodologies and directing resources toward department goals.
- Understanding of design controls and regulations and standards including US-IVD, IVD-D, IVD-R, China and Japan requirements, ISO 13485, IEC 62304, and 21 CFR 820.
- Ability to work effectively with senior leadership and cross-functional stakeholders.
Benefits
- Standard Monday–Friday work schedule.
- Office-based work environment.
Categories
About Thermo Fisher Scientific
Thermo Fisher Scientific builds analytical instruments, lab equipment and consumables, specialty diagnostics, and provides pharma services (CDMO and clinical research) for biotech, pharma, academic, and healthcare customers. It earns revenue through product sales, e-commerce distribution (Fisher Scientific), and contract services under brands such as Thermo Scientific, Applied Biosystems, Invitrogen, Patheon, and PPD. Headquartered in Waltham, MA, it is publicly traded on the NYSE (TMO) and was created by the 2006 merger of Thermo Electron and Fisher Scientific.