Software Verification Engineer

Overview

On Site
Full Time

Skills

Test Scripts
Test Plans
Functional Requirements
Test Execution
Regression Testing
Exploratory Testing
Test Cases
Reporting
Documentation
Management
Regulatory Compliance
Computer Science
Software Engineering
Biomedical Engineering
Software Testing
Testing
IBM Rational ClearQuest
Jama
Medical Devices
ISO 13485
Software Development
Test Methods
Analytical Skill
Conflict Resolution
Problem Solving
Attention To Detail
Scripting
Programming Languages
Python
Java
Automated Testing
Communication
Collaboration
Teamwork

Job Details

Job Description:
We are seeking a meticulous and detail-oriented Medical Device Software Verification Tester to join our team. The successful candidate will be responsible for verifying software used in our medical devices and ensuring compliance with regulatory standards and internal quality requirements. This role involves designing, implementing, and executing test plans and procedures to identify and document software defects.
Responsibilities:
  • Test Planning and Design.
  • Develop comprehensive test plans, test cases, and test scripts based on software requirements and design specifications.
  • Ensure test plans cover all functional and non-functional requirements, including performance, reliability, and security.
  • Test Execution:
  • Execute manual and automated tests to identify software application defects.
  • Conduct regression testing to ensure existing functionalities remain unaffected by new changes.
  • Perform exploratory testing to uncover potential issues not identified by formal test cases.
  • Documentation and Reporting:
  • Document test results, including detailed descriptions of defects and steps to reproduce them.
  • Generate and maintain test reports, defect logs, and other documentation required for regulatory compliance.
  • Communicate test outcomes and defect status to development teams and management.
  • Collaboration:
  • Work closely with software developers, and systems engineers, to understand software requirements and functionality.
  • Compliance and Standards.
  • Ensure testing activities comply with relevant regulatory standards (e.g., FDA, ISO 13485, IEC 62304).
  • Stay updated with industry best practices and evolving regulatory requirements for medical device software.
Requirements:
  • Bachelor's degree in computer science, Software Engineering, Biomedical Engineering, or a related field.
  • Minimum of 5+ years of experience in software testing, preferably in the medical device industry.
  • Experience with testing tools and frameworks (e.g., ClearQuest, Jama).
  • Familiarity with regulatory standards and guidelines for medical devices (e.g., FDA 21 CFR Part 820, ISO 13485, IEC 62304).
  • Strong understanding of software development and testing methodologies.
  • Excellent analytical and problem-solving skills.
  • Attention to detail and a high level of accuracy.
  • Proficiency in scripting or programming languages (e.g., Python, Java) for test automation.
  • Good communication and teamwork skills.
Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.