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Thermo Fisher Scientific

Makes lab instruments, reagents and supplies

Engineer 2 Software Test

Test Automation EngineeringConfirmed live in the last 24 hours
Full-timeBengaluru, Karnataka, IndiaNo salary listedHybrid

About the Job

Requirements

  • A bachelor's degree with at least 4–6 years of work experience and a strong record of industry productivity, or a preferred master's or PhD.
  • At least 4 years of experience performing software verification and validation testing, preferably in the medical device or biotechnology industry.
  • Strong understanding of next-generation sequencing-based regulated software, in-vitro diagnostic assay development practices, and informatics data analysis pipelines.
  • Practical experience leading the use of modern software development methodologies and processes, with the ability to direct resources to meet department goals.
  • 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 for in-vitro diagnostic and medical device software development, including ISO 13485, IEC 62304, and 21 CFR 820.
  • Ability to work effectively with senior leadership.
  • Strong coding skills and a solid understanding of quality assurance principles and continuous integration methods.

Responsibilities

  • Define the scope and design automated and manual tests for bioinformatics software.
  • Develop and implement software testing strategies, methods, and best practices for high-quality next-generation sequencing analytics and instrument software products intended for regulated in-vitro diagnostic and medical device markets.
  • Apply established software quality standards and key performance indicator metrics to help measure software and bioinformatics product quality.
  • Work with leads to implement software quality-tracking tools and methodologies that provide ongoing visibility and enable action during the software product development lifecycle.
  • Work with leads and 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 and manage project testing activities.
  • Partner with internal and external stakeholders to define requirements for regulated assays and software, and help the software development team understand complex informatics and visualization requirements for design implementation.
  • Write positive and negative smoke and regression test scripts to test product functionality and integration with dependencies.
  • Drive test strategies for application programming interfaces, user interfaces, web services, and web applications, and write performance, load, and stress tests.
  • Participate in an Agile/Scrum setting and partner with users and team members to determine approaches for system validation.

Desired Qualifications

  • Experience with software development and test engineering in clinical and research settings.
  • Experience performing software verification and validation testing in the medical device or biotechnology industry.

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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