Staff Engineer, Software V&V
Thermo Fisher Scientific11 hours ago
Bengaluru, IndiaStaff+
Responsibilities
- Develop and implement software verification, validation, testing strategies, methods, and best practices for regulated NGS analytics and instrument software.
- Lead and mentor bioinformatics and software test engineers.
- Define software quality standards and KPI metrics and maintain quality tracking and visibility throughout the product lifecycle.
- Serve as a point of contact for external partners delivering software products.
- Coordinate testing scope and overall verification and validation activities with software, bioinformatics, functional, and project leadership.
- Partner with stakeholders to define regulated assay and software requirements and clarify informatics and visualization needs.
- Develop and drive automated and manual smoke, regression, API, user-interface, web-service, performance, load, and stress testing.
Requirements
- Bachelor’s degree with at least 10 years of relevant work experience and a strong industry productivity record; a master’s or PhD is preferred.
- At least 10 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 activities, including cross-functional and multi-site teams.
- Experience using modern software development methodologies and directing resources to meet department goals.
- Understanding of design controls and regulations and standards including US-IVD, IVD-D, IVD-R, China and Japan regulations, ISO 13485, IEC 62304, and 21 CFR 820.
- Strong leadership and communication skills, including the ability to work with senior leadership and in fast-paced, dynamic environments.
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.