Test Engineer- 9330

Overview

• Verification and Validation of software for complex system interactions in medical devices, includingo Application softwareo Embedded softwareo Platform softwareo Operating system software
• With minimal assistance, develop and execute manual and/or automated software verification protocols, including:
• Design and development of test scenarioso Authoring and review of test cases and protocolso Performing execution of test cases
• Writing reports
• Responsible for verification of the software platform of the medical device, including:
• User interface and interactions o Performance and reliability
• Safety and interoperability
• Ability to review and understand product and software requirements
• Effectively communicate issues observed while documenting the same with necessary details
• Assist in reproducing and analyzing potential defects found in testing
• A good understanding of standard operating procedures for medical device development, including compliance with ISO 13485 and IEC 62304
• Engaging in continuous improvement initiatives to establish Center of Excellence (CoE) in Software Assurance function.
  
  

Mandatory Requirements:

• Minimum of 2 years of relevant work experience in software testing in medical device or in a regulated industry.
• Thorough knowledge of the software testing lifecycle with the ability to design and execute test protocols effectively
• Foundational coding skills in languages commonly used in test automation (e.g., Python, Java, or C#).
• The candidate is expected to work from the office.Skill & Competency Requirements:
• Bachelor’s degree in engineering, preferably Computer, Electronics, or Biomedical
• Exposure to software test automation and ability to adapt and learn test automation.
• Strong attention to detail and ability to follow instructions
• Familiarity with Software Development Lifecycle processes, including Waterfall and Agile methodologies
• Technical writing ability – clear and concise writing easily understood by multiple audiences (testers, auditors, peers, etc.)
• Have a strong sense of ownership and project outcome.Preferences:
• Exposure to designing and developing medical device software in a regulated environment while adhering to FDA Design Controls and software process guidelines for medical devices including ISO 13485 and IEC 62304
• Working knowledge of tools such as Rational Quality Manager, Jenkins, TOSCA, Squish, JIRA,Git version control.
• Working knowledge on OS such as Windows, Linux flavors
• Ability to troubleshoot and make quick knowledge and experience-guided decisions
• Excellent people skills, ability to partner well, good team camaraderie