Staff Engineer, Software V&V
Thermo Fisher Scientific11 days ago
Bengaluru, IndiaStaff+
Responsibilities
- Develop and implement software verification, validation, testing strategies, methods, and best practices for regulated NGS analytics and instrument software.
- Design and drive automated and manual positive and negative smoke, regression, integration, performance, load, and stress testing.
- Lead and mentor bioinformatics and software test engineers, including cross-functional and multi-site teams.
- Establish software quality standards, KPI metrics, quality tracking tools, and lifecycle visibility for software and bioinformatics products.
- Serve as a point of contact for external partners delivering software products to market.
- Partner with software, bioinformatics, project, and functional leadership to define testing scope and manage overall project testing activities.
- Partner with stakeholders to establish requirements for regulated assays and software and clarify informatics and visualization requirements.
Requirements
- Bachelor’s degree with 10+ years of relevant work experience; a master’s degree or PhD is preferred.
- 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 teams, with strong leadership and mentoring abilities.
- Experience directing modern software development processes and resources to meet department goals.
- Understanding of design controls and applicable IVD and medical-device software regulations and standards, including US-IVD, IVD-D, IVD-R, 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-Friday work schedule in an office 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.