Software Verification And Validation Engineer

POSITION/TITLE: Software V&V Engineer

DEPARTMENT/TEAM DESCRIPTION

Name: Radiology Software Assurance & Operations Team.

Primary Function:

• System software verification and validation of radiology device products to meet FDA design controls

POSITION SUMMARY

This position will be responsible to perform software verification and validation of medical devices to deliver a high-quality product that meets or exceeds customer expectations and meets FDA design controls.

POSITION DUTIES & RESPONSIBILITIES

Activities

• Verification and Validation of software for complex system interactions in medical devices, including
• Application software
• Embedded software
• Platform software
• Operating system software
• With minimal assistance, develop and execute manual and/or automated software verification protocols, including:
• Design and development of test scenarios
• Authoring and review of test cases and protocols
• Performing execution of test cases
• Writing reports
• Responsible for verification of the software platform of the medical device, including:
• User interface and interactions
• 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.

REQUIREMENTS/PREFERENCES

Skill & Competency Requirements:

• Bachelors degree in engineering, preferably Computer, Electronics, or Biomedical
• Minimum of 2 years of relevant work experience in software testing in medical device or in a regulated industry
• Exposure to software test automation and ability to adapt and learn test automation. Basic skills in relevant programming languages (e.g., Python, Java) and test automation tools
• 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.
• This position requires the candidate to work from office

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 and DOORS Next Gen
• Working knowledge on OS such as Windows, Linux flavors
• Demonstrated ability working in a matrix/hybrid organization structure
• Ability to troubleshoot and make quick knowledge and experience-guided decisions
• Excellent written and oral communication
• Excellent people skills, ability to partner well, good team camaraderie
• Proficient with Microsoft Office tools especially MS Word, MS Excel, MS PowerPoint, MS Project, and other management tools