Engineer II Software Test

Overview

Engineer III, Software Test at Thermo Fisher Scientific, leading software verification and validation for highly advanced bioinformatics software in a regulated environment.

What you'll do

• Define scope and design automated and manual tests for 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.
• Develop and implement software testing strategy, methods and best practices for NGS analytics and instrument software released into the regulated in-vitro diagnostics/medical device space.
• Work on established software quality standards and KPI metrics to measure software and bioinformatics product quality.
• Work with Leads to implement software quality tracking tools and methodologies for visibility during the product development lifecycle.
• Partner with software and bioinformatics leadership, functional and project managers to identify the scope of testing, verification and validation required 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.
• Work with external partners to deliver state-of-the-art software products to market.

What you'll need

• Master's or PhD preferred, or Bachelor's with minimum 4-6 years of work experience and a strong track record of industry productivity.
• 4+ years of experience performing software verification and validation testing, preferably in the medical device/biotech space.
• Strong coding skills.
• Solid understanding of Quality Assurance principles and Continuous Integration methods.
• Strong understanding of NGS-based regulated software, IVD assay development practices and informatics data analysis pipelines.
• Practical experience as a leader in modern software development methodologies/processes, with an 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 applicable regulations and standards for IVD and medical device software development (e.g. ISO 13485, IEC 62304, 21 CFR 820).
• Ability to work well with senior leadership.

Details

• Work schedule: Standard (Mon-Fri).
• Environmental conditions: Office.
• Location: Bangalore, India.