Staff Engineer, Software V&V

Overview

Staff Engineer, Software V&V role leading software verification and validation for NGS bioinformatics and instrument software in a regulated in-vitro diagnostics and medical device environment.

What you'll do

• Develop and implement software testing strategy, methods and best practices for high quality NGS analytics and instrument software products released into the regulated IVD and medical device space.
• Lead and mentor a group of bioinformatics and software test engineers.
• Establish software quality standards and KPI metrics to measure software and bioinformatics product quality.
• Implement software quality tracking tools and methodologies to provide ongoing visibility and action during the product development lifecycle.
• Act as single point of contact while working with external partners to deliver state of the art software products in market.
• Partner with software and bioinformatics leadership, functional and project managers to identify the appropriate scope of testing, verification and validation for a project and manage overall testing activities.
• Partner with internal and external stakeholders to drive requirements for regulated assays and software, and help the software development team understand complex informatics and visualization requirements leading into design implementation.
• Define scope, design, and build automated and manual tests for highly advanced bioinformatics software.
• Drive writing of positive and negative smoke and regression test scripts to test product functionality and integration with dependencies.
• Drive strategies for test APIs, user interfaces, web services and/or web apps, and write performance, load, and stress tests.

What you'll need

• Masters/PhD preferred, or Bachelors with minimum 10+ years of work experience and a strong track record of industry productivity.
• 10+ years of experience performing software verification and validation testing, preferably in the medical device or 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.
• Practical experience as a leader in modern software development methodologies/processes, with ability to direct resources to meet department goals.
• Good understanding of design control for regulated products (e.g. US-IVD, IVD-D, IVD-R, China and Japan regulations) and of applicable regulations and standards for IVD and medical device software (e.g. ISO 13485, IEC 62304, 21 CFR 820).
• Ability to work well with senior leadership.
• Experience working in a fast paced, dynamic environment.
• Strong coding skills and a solid understanding of Quality Assurance principles and Continuous Integration methods.
• Experience with software development and test engineering in clinical and research settings.

Nice to have

• Experience leading cross-functional, multi-site teams.

Details

• Location: Bangalore, India.
• Work schedule: Standard (Mon-Fri).
• Participation in an Agile/SCRUM setting.