Lead Verification

3 weeks ago

Thane Maharashtra India, Maharashtra Digital Health Solutions Full time

We are currently seeking a talented Senior Verification & Validation Engineer to join our dynamic team. The ideal candidate will have extensive experience in system engineering, requirement management, risk management, verification and validation, navigating the cybersecurity guidance, as well as a deep understanding of the medical device industry.


Job Title: Senior Verification & Validation Engineer


Experience: 5 - 10 Years


Qualification: B.E/B.Tech or equivalent degree in Electronics Engineering / Computer Science.


Job Description:

Biovantage is looking for a qualified Senior Verification & Validation Engineer to perform end to end software verification and validation for our various Medical Device and Software as a Medical Device product development projects.


As a Senior V&V Engineer, you will be actively involved in understanding / authoring the software requirements, developing test protocols, executing test cases, and automating those test cases. You will continuously track software bugs and control the overall quality of the software.


Required Skills:

  • Experience in software testing and automation for Embedded Software, Web Applications & Mobile Applications.
  • Excellent aptitude and reasoning with understanding of Software QA methodologies, tools, and processes.
  • Experience in development, execution and review of software verification plan, test methods, test strategies, acceptance criteria, test cases, test reports, and traceability reports.
  • Experience working in an ISO 13485 compliant environment.
  • Strong problem-solving skills to participate in troubleshooting of issues with different teams to drive towards root cause identification and resolution.
  • Good team player with excellent communication skills, to be able to collaborate and work with cross functional teams.
  • Ability to work in a fast-paced, dynamic work environment with a focus on technical excellence, responsiveness to meet timelines.
  • Ability to work on multiple projects in a deadline driven environment.


Preferred Skills:

  • Experience in software testing for medical domain products.
  • Experience in building test automation framework.
  • Familiarity with Requirements management tools, configuration management tools and test management tools like Git, TestRail, Jira, Helix/TestTrack, Confluence, etc.
  • Experience with software and system risk analysis (per ISO 14971) including fault tree analysis, software failure mode and effects analysis (FMEA).
  • Experience with FDA Guidance for Cybersecurity in Medical devices including threat modelling techniques and security risk management.


Responsibilities:

  • Responsible for the verification and validation of a medical software, including but not limited to development of software verification plan, review of system and subsystem requirements, design test strategies and methods, write and execute test cases, generate traceability reports, generate test execution reports.
  • Identify / build test automation tools and framework, automate test cases.
  • Collaborate with Product development teams to understand the product specification, system interfaces, operational requirements, performance requirements, software requirements, software design, etc. to discuss and review test methods and test strategies.
  • Participate in review meetings with cross functional teams and contribute to writing software requirements, developing software verification protocol, etc.
  • Teach and mentor fellow engineers, and work to foster an environment of development and inclusivity.


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