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Thermo Fisher Scientific

Makes lab instruments, reagents and supplies

Software Test Engineer 3

Engineering LeadershipConfirmed live in the last 24 hours
Full-timeBengaluru, Karnataka, IndiaNo salary listedHybrid

About the Job

Requirements

  • A Bachelor's degree with at least six years of work experience and a strong track record of industry productivity, or a preferred Master's or PhD degree.
  • At least six years of experience performing software verification and validation testing, preferably in the medical-device or biotechnology space.
  • Strong understanding of next-generation sequencing (NGS)-based regulated software, in-vitro diagnostic (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; experience leading cross-functional, multi-site teams is preferred.
  • Practical experience leading the use of modern software development methodologies and processes, with the ability to direct resources to meet department goals.
  • Good understanding of design control for regulated products, including 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, such as ISO 13485, IEC 62304, and 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.

Responsibilities

  • Develop and implement software testing strategy, methods, and best practices for designing, developing, and releasing high-quality NGS analytics and instrument software products in the regulated in-vitro diagnostics and medical-device space.
  • Lead and mentor a group of bioinformatics and software test engineers.
  • Establish software quality standards and key performance indicator (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.
  • Serve 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 appropriate software-testing, verification, and validation scope for projects, and manage overall 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.
  • Define scope and design automated and manual tests for bioinformatics software.
  • Write positive and negative smoke and regression test scripts to test product functionality and integration with dependencies.
  • Drive testing strategies for application programming interfaces (APIs), user interfaces, web services, and/or web applications, and write performance, load, and stress tests.

Desired Qualifications

  • A Master's or PhD degree.
  • Experience in the medical-device or biotechnology space.
  • Experience leading cross-functional, multi-site teams.

About the Company

Thermo Fisher Scientific

Makes lab instruments, reagents and supplies

Thermo Fisher Scientific makes and sells the instruments, chemicals, consumables and lab services that drug companies, hospitals, universities and industrial labs use for research, testing and production. Its products cover work from gene sequencing and protein analysis to diagnostic tests and lab freezers, and its distribution arm ships supplies to labs worldwide. Drug developers also hire it to run clinical trials and to manufacture medicines under contract. It earns money from consumables that labs buy again and again, along with instrument sales, service contracts and outsourcing fees. The company traces its roots to Thermo Electron, founded in 1956, which merged with Fisher Scientific in 2006, and it is based in Waltham, Massachusetts.

Company size
10,001+
Company stage
IPO
Headquarters
Waltham, MA
Founded
1956

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