Engineer III Software Test
Thermo Fisher Scientific1 month ago
Bengaluru, IndiaSenior
Responsibilities
- Develop and implement software testing strategies, methods, and best practices for regulated NGS analytics and instrument software.
- Lead and mentor bioinformatics and software test engineers, including cross-functional and multi-site teams.
- Establish software quality standards, KPI metrics, tracking tools, and ongoing quality visibility throughout the product lifecycle.
- Serve as a point of contact with external partners delivering software products to market.
- Coordinate project-level software testing, verification, and validation activities with software and bioinformatics leadership and project managers.
- Partner with stakeholders to define requirements for regulated assays and software and support informatics and visualization design implementation.
- Create and direct automated and manual smoke, regression, API, user-interface, web-service, performance, load, and stress testing.
Requirements
- Bachelor's degree with at least 6 years of work experience; a master's degree or PhD is preferred.
- At least 6 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.
- Extensive experience leading software quality engineering and assurance teams and strong leadership abilities.
- Experience directing modern software development methodologies and allocating resources to meet department goals.
- Understanding of design control for regulated products and regulations and standards including US-IVD, IVD-D, IVD-R, China and Japan regulations, ISO 13485, IEC 62304, and 21 CFR 820.
- Ability to work effectively with senior leadership and in a fast-paced, dynamic environment.
Benefits
- Standard Monday-through-Friday work schedule.
- Office-based work environment.
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.