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Quality Assurance Software Engineer

2 months ago

Portsmouth, Virginia, United States Aversan Inc. Full time

Position Overview

The Software Test Engineer plays a crucial role in the planning, execution, and documentation of verification processes for software systems and medical devices. This individual will collaborate with a multidisciplinary team to comprehend the assigned tasks and enhance product quality. As a proactive team member, the engineer will focus on driving effectiveness, efficiency, and adherence to compliance standards.

Key Responsibilities

  • Evaluate and provide insights on existing test verification practices to ensure alignment with FDA/ISO regulations.
  • Collaborate with leadership and development teams to implement best practices.
  • Develop and refine processes and procedures for design verification, including the identification of essential tools.
  • Contribute to the clarification of requirements and user stories to integrate verification considerations.
  • Exhibit expertise in creating test cases for system-level testing.
  • Produce high-quality, compliant test plans and cases using Microsoft TFS/Azure DevOps and related tools.
  • Design, implement, and execute both manual and automated testing scenarios.
  • Assist in defining strategies for system-level testing.
  • Support the design and development of testing systems necessary for verification.
  • Engage in requirements development and system-level document evaluations.
  • Manage defect logging, tracking, and reproduction processes.
  • Provide constructive feedback to enhance various verification-related processes.
  • Participate in bug reproduction, logging, and triage activities.
  • Occasionally oversee project management for development initiatives.
  • Identify challenges and meet project deadlines while performing additional tasks as assigned.

Qualifications

  • A degree or certification in a scientific or technical discipline, or relevant professional experience.
  • Extensive experience in design verification for medical software devices.
  • Proficiency with Microsoft Test Manager (MTM) and Microsoft TFS/Azure DevOps.
  • Experience in both manual and automated testing environments.
  • Familiarity with Agile testing methodologies.
  • Knowledge of testing and troubleshooting peripheral device communication and connectivity (e.g., Bluetooth/USB).
  • Experience in testing systems within the medical industry.
  • Understanding of FDA's Quality System Regulation (CFR 820) and/or ISO 13485 is advantageous.