Description

Responsibilities:

• Follow all applicable Monteris Quality System Standard Operating Procedures as well as various applicable FDA, ISO, CSA, and EU regulations and Guidance Documents
• Handle all matters using a high level of judgment, responsibility, and professionalism
• Develop, execute, and maintain automated test scripts and test tools using C#, WPF, and C++ to support software development and verification activities
• Execute manual and automated test protocols and test cases in accordance with approved test plans, requirements, and design specifications
• Build and maintain automated test cases and test suites using NUnit, Google Test, JUnit, or other equivalent automated test frameworks
• Set up, configure, and maintain test environments, hardware/software test benches, and laboratory equipment required for verification testing
• Record, document, and report test results, defects, and anomalies with clear, accurate, and traceable documentation
• Support defect identification, logging, tracking, and retesting through resolution and closure
• Assist in the development and revision of test cases, test scripts, and test procedures in response to requirement and design changes
• Maintain traceability between requirements, test cases, and test results within Jama
• Support automated test execution, monitoring, and reporting through Jenkins CI/CD pipelines
• Collaborate with software engineers, verification analysts, and quality personnel to ensure thorough and accurate test coverage
• Participate in the review of test protocols, test scripts, and test reports
• Support troubleshooting and root-cause investigation of software defects identified during testing
• Support testing of image processing and visualization features, including DICOM-based imaging workflows, as applicable to assigned projects
• Participate in the risk planning process as requested or required
• Support audits, inspections, and regulatory submissions by ensuring test documentation is complete, accurate, and audit ready

Qualifications:

• Strong analytical, troubleshooting, and root-cause investigation skills
• Solid understanding of the software development lifecycle (SDLC), software test methodologies, and software quality assurance principles
• Ability to read and interpret software requirements, design specifications, and test protocols
• Strong attention to detail with a commitment to accurate, thorough, and traceable documentation
• Good organizational and time-management skills with the ability to manage multiple test activities and deadlines
• Effective verbal and written communication skills, including the ability to clearly document and report defects and results
• Ability to work collaboratively with software engineers, verification and validation staff, and quality personnel
• Ability to work effectively in a fast-paced, regulated development environment
• Willingness to learn new tools, frameworks, and imaging technologies as needed
• Ability to retain information on a confidential basis
• Associate’s degree or technical certification in software engineering, computer science, engineering technology, or a related field required; Bachelor’s degree preferred
• Minimum of five (5) years of experience in software development and/or software testing
• Application development experience with C# and WPF
• Experience with C++ software development and/or test automation
• Hands-on experience with automated test frameworks such as NUnit, Google Test, JUnit, or comparable frameworks
• Experience executing software verification and validation activities, preferably within a regulated environment
• Experience with VTK/ITK and DICOM image processing and visualization is considered an asset
• Experience with requirements management tools such as Jama and automation orchestration tools such as Jenkins is considered an asset

Key Skills

Education

Bachelor's degree