Engineer III, Software Test

Overview

Lead software verification and validation for advanced bioinformatics software, defining the scope and design of automated and manual tests. The role focuses on quality engineering for NGS analytics and instruments software products developed for the regulated in-vitro diagnostics and medical device space.

What you'll do

• Develop and implement software testing strategy, methods and best practices for high-quality NGS analytics and instruments software products.
• Define and design automated and manual tests for advanced bioinformatics software.
• Write positive and negative smoke and regression test scripts for product functionality and integration with dependencies.
• Develop testing strategies for APIs, user interfaces, web services and/or web apps.
• Write performance, load and stress tests.
• 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 software product development lifecycle.
• Act as the single point of contact while working with external partners to deliver software products to market.
• Partner with software and bioinformatics leadership, functional managers and project managers to identify the appropriate scope of software testing, verification and validation required for projects and manage overall project testing activities.
• Partner with internal and external stakeholders to drive requirements for regulated assays and software.
• Help the software development team understand complex informatics and visualization requirements leading into design implementation.
• Participate in an Agile/SCRUM setting to meet and exceed customer expectations and drive continuous quality improvements.
• Partner with users and other team members to determine approaches to validating systems.

What you'll need

• Masters/PhD preferred or a Bachelor's degree with minimum 08 years of work experience and a strong track record of industry productivity.
• 08+ experience performing software verification and validation testing, preferably in the medical device/biotech space.
• Strong coding skills.
• A 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.
• Strong leadership abilities and extensive experience managing the activities of software quality engineering and assurance teams.
• Practical experience as a leader in the use of modern software development methodologies/processes, with an ability to direct the use of resources to meet department goals.
• Good understanding of design control for regulated products, including US-IVD, IVD-D, IVD-R, China and Japan regulations.
• Knowledge of applicable regulations and standards used in IVD and medical device software development, including ISO 13485, IEC 62304 and 21 CFR 820.
• Ability to work well with senior leadership.
• Experience working in a fast-paced, dynamic environment.

Nice to have

• Masters/PhD.
• Experience in the medical device/biotech space.
• Experience leading cross-functional, multi-site teams.

Details

• Location: Bangalore, India.
• Work schedule: Standard, Monday-Friday.
• Work environment: Office.