Lead Verification And Validation Engineer

Verification And

Job Title

Experience

Qualification

Biovantage is looking for a Verification and Validation Lead Engineer to perform end-to-end software/firmware verification and validation for our various Medical Device and Software as a Medical Device (SaMD) product development projects.

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

Required Skills:

• 10-13 years of experience in system/software/firmware verification and validation with a focus on any of the regulated industry such as medical device, avionics, or automotive.
• Experience in software testing for Embedded Software/Firmware, Web Applications & Mobile Applications.
• Excellent aptitude and reasoning with understanding of Software testing/verification methodologies, tools, and processes.
• Experience in development, execution and review of verification plans, test methods, test strategies, acceptance criteria, test cases, test reports, and traceability reports.
• Excellent problem-solving skills and the ability to work independently or as part of a team.
• Good team player with excellent communication skills, to be able to collaborate and work with cross functional teams.
• Knowledge of IEC 62304, ISO 13485, ISO 14971 and other relevant medical device regulations and standards.
• Experience generating technical documentation such as product requirements, specifications, engineering reports, test plans & procedures, validation plans and reports.
• Ability to work on multiple projects in a deadline driven environment.
• Strong track record of technical leadership and working in cross-functional teams.
• Project management skills including planning and estimation of task and milestones desired.
• Strong communication skills, both written and verbal, with the ability to effectively convey complex technical concepts to non-technical stakeholders

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Preferred Skills:

• 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

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Responsibilities:

• Participate in the development of system and subsystem requirements development and review.
• Lead and contribute to verification and validation of a Medical Device product hardware and software, including but not limited to development of 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.
• 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.
• Manages technical and schedule balance while coordinating with the project manager and functional leads to ensure the planned approach meets schedule constraints.
• Performs hands-on system integration testing and troubleshooting of technical issues.
• Performs system level verification against requirements. Creates test plans, procedures and reports, performs, and analyses system set up, and conducts verification and validation activities.
• Mentor fellow V&V engineers and work to foster an environment of individual development and organization growth.
• Helps grow the organization by participating in interview process for engineers of various disciplines, working closely with senior leadership.
• Stay current with industry trends, regulatory guidance, standards, and best practices in medical devices industry to continuously improve our services and maintain our competitive edge.

Location: Thane