Staff Engineer, Software Test
On-siteBengaluru, Karnataka, India
Job Summary
Develop and implement software testing strategies, methods, and best practices for NGS analytics and instrument software designed for the regulated in-vitro diagnostics and medical device space. Lead a team of bioinformatics and software test engineers, establishing quality standards, KPI metrics, and tracking tools to measure product quality throughout the development lifecycle. Drive the creation of automated and manual test scripts, including smoke, regression, performance, load, and stress tests, while partnering with leadership to define testing scope and manage overall activities. Mentor engineers, conduct test case reviews, and serve as the single point of contact for external partners delivering state-of-the-art software products. Work within an Agile/SCRUM environment to identify risks, mitigate issues, and drive continuous quality improvements for complex informatics and visualization requirements.
Required Qualifications
- Masters/PhD preferred or Bachelors with minimum 10+ years of work experience and strong track record of industry productivity
- 08+ experience performing software verification and validation testing, preferably in the medical device/ biotech space
- Strong understanding of NGS-based regulated software, IVD assay development practices and informatics data analysis pipelines
- Strong leadership abilities and extensive experience managing the activities of software quality engineering and assurance teams
- Good understanding in design control for regulated products (e.g. US-IVD, IVD-D, IVD-R, China and Japan regulations) and knowledge of applicable regulations and standards used in IVD and medical device software development (e.g. ISO 13485, IEC 62304, and 21 CFR 820)
Desired Qualifications
- Experience leading cross-functional, multi-site teams preferred
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