Job Title: Software Test Engineer Job Description The Software Test Engineer is responsible for testing software used in new and existing medical device products. This role designs and executes black box, white box, and grey box tests at both the software and system levels, ensuring that all testing is comprehensive, repeatable, and fully documented. The engineer creates detailed test plans, protocols, traceability matrices, and test reports based on software and product requirements, and supports the review of requirements for accuracy and testability.
The position plays a key role in maintaining compliance with the medical device quality management system by properly creating, tracking, and storing testing documentation. Responsibilities Design and execute black box, white box, and grey box tests for software used in medical device products at both the software and system levels. Develop comprehensive and repeatable test plans, test protocols, traceability matrices, and test reports based on software and product requirements.
Implement and run test cases to verify and validate software functionality, performance, and reliability in support of medical device product development. Assist in reviewing software and product requirements to confirm accuracy, clarity, and testability. Ensure all testing activities comply with the medical device quality management system, including proper creation, tracking, and storage of testing documentation.
Participate in software verification efforts for firmware, embedded software, and implantable Class III medical devices. Use issue tracking tools such as JIRA (or equivalent) to document, track, and communicate software defects and test results. Collaborate with cross-functional teams, including engineering and product development, to support timely resolution of issues identified during testing. Contribute to risk management activities related to software testing in accordance with relevant medical device standards.
Support continuous improvement of test methods, tools, and documentation practices within the software testing process. Essential Skills Experience designing and executing black box, white box, and grey box software tests at the software and system levels. Ability to create comprehensive and repeatable test plans, test protocols, traceability matrices, and test reports. Knowledge of software verification practices for firmware, embedded software, and implantable Class III medical devices.
Familiarity with medical device quality management systems and compliance requirements for testing documentation. Proficiency using Word and Excel for documentation and reporting. Experience with JIRA or other issue tracking software to manage defects and testing activities. Experience with PDM or other project data management software for organizing project and test artifacts. Some hands-on experience working with programming languages such as C, C++, C#, and Java.
Ability to review and interpret software and product requirements and translate them into effective test cases. Additional Skills & Qualifications Preferred experience with IEC standards relevant to medical device software. Preferred experience with ISO-based risk management for medical devices. testing software for medical devices across Class I, II, and III products. Experience working with embedded C in medical or implantable device environments.
Understanding of risk management principles as applied to software verification and validation. Strong attention to detail and a methodical approach to documentation and test execution. Effective communication skills for collaborating with multidisciplinary engineering and product teams. Work Environment The role is based in a medical device product development environment that focuses on innovative design solutions and comprehensive development services for Class I, II, and III devices across a range of clinical applications.
The Software Test Engineer works closely with engineering and