Staff Engineer, Software V&V

Overview

Staff Engineer, Software V&V at Thermo Fisher Scientific, leading software testing, verification and validation for NGS bioinformatics and instrument software in a regulated IVD and medical device environment.

What you'll do

• Develop and implement software testing strategy, methods and best practices for NGS analytics and instrument software released into the regulated IVD/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 for ongoing visibility and action during the product development lifecycle.
• Act as single point of contact for external partners delivering software products to market.
• Partner with software and bioinformatics leadership, functional and project managers to define the scope of testing, verification and validation for projects and manage overall testing activities.
• Partner with internal and external stakeholders to drive requirements for regulated assays and software, and help the development team understand complex informatics and visualization requirements.
• 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.
• Participate in an Agile/SCRUM setting to meet and exceed customer expectations and drive quality improvements.

What you'll need

• Master's or PhD preferred, or Bachelor's 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 software quality engineering and assurance teams.
• Practical experience leading 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, a solid understanding of Quality Assurance principles and Continuous Integration methods.

Nice to have

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

Details

• Location: Bangalore, India.
• Work schedule: Standard (Mon-Fri), office environment.