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