Lead Software Test Verification Engineer

Seeking a Lead Software Test Verification Engineer to lead software verification and validation activities for regulated medical device products. This role will provide technical leadership to a team of Software Test Engineers while ensuring software quality, safety, and compliance throughout the product development lifecycle., * Lead and mentor a team of 3 Software Test Engineers.

• Develop and execute software V&V test plans, protocols, and reports.
• Coordinate functional, integration, system, regression, and performance testing activities.
• Ensure requirements traceability and complete test documentation.
• Review test results, investigate defects, and support root cause analysis.
• Collaborate with Software, Systems, QA, Regulatory, and Program Management teams.
• Ensure compliance with FDA regulations, IEC 62304, ISO 13485, and quality system requirements.
• Communicate testing progress, risks, and results to stakeholders.
• Support audit readiness and continuous process improvement initiatives., Use of Artificial Intelligence (AI): We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools. Related Jobs Test Engineer Leidos

Eagan, MN*Remote

CI/CD Junit Gitlab Github Newman Jenkins Dataflow Aviation Equities Debugging Scripting

Auditing Testrail Visionary IEC 62304 Mentorship Innovation Azure DevOps Communication Test Planning Test Automation FDA Regulations Medical Devices Computer Science Safety Assurance Software Systems Embedded Systems Software Testing Agile Methodology Connected Devices Defect Management Program Management ISO 13485 Standard ISO 14971 Standard Root Cause Analysis Performance Testing Technical Leadership Waterfall Methodology Stakeholder Management Biomedical Engineering New Product Development Polarion ALM (Software) Requirements Traceability Quality Management Systems Engineering Design Process Software Quality (SQA/SQC) Verification And Validation Software Testing Life Cycle Continuous Improvement Process Systems Development Life Cycle Troubleshooting (Problem Solving), * Bachelor’s degree in Engineering, Computer Science, Biomedical Engineering, or related field.

• 8+ years of software testing, verification, or validation experience.
• 2+ years of experience leading or mentoring test engineers.
• Experience developing and executing software V&V test plans.
• Strong understanding of SDLC, STLC, requirements-based testing, and traceability.
• Experience in a regulated medical device environment.
• Knowledge of FDA Quality System Regulations and medical device standards.
• Strong troubleshooting, defect management, and root cause analysis skills.
• Excellent communication and stakeholder management abilities., * Experience with Class II or III medical devices.
• Knowledge of IEC 62304, ISO 14971, ISO 13485, and FDA Design Controls.
• Experience with automated testing frameworks and test automation.
• Familiarity with Agile and/or Waterfall methodologies.
• Experience using Jira, Azure DevOps, Polarion, DOORS, TestRail, or similar tools.
• Background supporting embedded systems, connected devices, or other safety-critical products., Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors., Kubernetes SAFe Agile Testability Market Data API Testing Quality Gate REST Assured Communication Investigation Microservices Test Planning ANSYS Meshing Apache JMeter Responsible AI Test Automation Code Generation Defect Tracking Test Management Computer Science Scenario Testing Test Engineering Security Testing Contract Testing Agile Methodology Docker (Software) Programming Tools Chaos Engineering Workflow Management Root Cause Analysis Systems Engineering Integration Testing Selenium (Software) Performance Testing Data-Driven Testing Software Engineering Postman API Platform Test Data Management Engineering Practices Hybrid Cloud Computing Air Traffic Management Service Virtualization Education and Training Event-Driven Programming Software Quality (SQA/SQC) Java (Programming Language) Behavior-Driven Development Python (Programming Language) Test-Driven Development (TDD) JavaScript (Programming Language) Application Programming Interface (API) +0

Google IT Automation with Python Lead Software Verification & Validation Engineer Actalent

Minneapolis, MN*On-Site

JIRA Auditing Testrail Visionary IEC 62304 Mentorship Innovation Azure DevOps Communication Test Planning Test Automation FDA Regulations Medical Devices Computer Science Safety Assurance Software Systems Embedded Systems Software Testing Agile Methodology Connected Devices Defect Management Program Management ISO 13485 Standard ISO 14971 Standard Root Cause Analysis Performance Testing Technical Leadership Waterfall Methodology Stakeholder Management Biomedical Engineering New Product Development Polarion ALM (Software) Requirements Traceability Quality Management Systems Engineering Design Process Software Quality (SQA/SQC) Verification And Validation Software Testing Life Cycle Continuous Improvement Process Systems Development Life Cycle Troubleshooting (Problem Solving)

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