Software Test Engineer

Job Title

Software Test Engineer

Software verification, validation, and testing for a high‑reliability medical device product that includes embedded firmware, mobile applications, and cloud‑connected applications. The Software Test Engineer applies software quality engineering principles throughout an agile product lifecycle, ensuring that software requirements, design, and implementation meet stringent medical device standards and regulatory expectations.

• Support the verification and validation of software for an electromechanical medical device, including firmware, embedded systems, mobile applications, and cloud-connected applications.
• Review software development and testing activities to ensure compliance with documented requirements, established standards, and medical device regulations.
• Apply software quality engineering principles throughout the agile product life cycle to identify defects, design flaws, and process improvement opportunities.
• Review software requirements to confirm they are correct, complete, and unambiguous, and provide feedback to improve clarity and testability.
• Develop, review, and execute test plans and test procedures based on use cases, software requirements, and established test protocols.
• Assist in updating and adding new test cases to existing test protocols to maintain comprehensive test coverage.
• Manage testing tasks for embedded software and firmware, ensuring thorough functional, integration, and system‑level testing.
• Review and refine test methods and test plans to verify software design accuracy against documented requirements and applicable standards.
• Collaborate closely with software development and systems engineering teams to improve the quality of deliverables and to introduce quality‑related improvements in the software development process.
• Prepare and review test plans, test data, and test scripts, and conduct system and integration testing across firmware, mobile, and cloud components.
• Integrate automated tests into Continuous Integration and Continuous Deployment (CI/CD) pipelines to enable real‑time quality monitoring.
• Document test results and engineering data accurately within a Quality Management System (QMS) or related configuration/document management system.
• Contribute to test automation strategy and implementation to increase efficiency and repeatability of testing activities.
• Participate in the testing and validation of cloud‑based data storage and processing solutions associated with the medical device.
• Support testing and validation of mobile applications and other software applications related to the medical device ecosystem.

• At least 5–6 years of relevant experience in software testing, validation, and verification for high‑reliability software products.
• Hands‑on experience in the medical device field, including work with relevant quality and safety standards such as ISO and IEC standards for medical devices.
• Proven experience testing embedded software and firmware for electromechanical or embedded systems.
• Strong background in software test engineering, including test planning, test procedure development, and execution of verification and validation activities.
• Experience documenting test results and engineering data within a Quality Management System (QMS) or related configuration/document management system.
• Exposure to or experience with cloud technologies used for data storage and processing, such as AWS, Azure, or similar platforms.
• Ability to review and interpret software requirements and translate them into effective test plans, test cases, and test protocols.
• Experience working within an agile software development lifecycle and applying software quality engineering principles.
• Bachelor’s degree in engineering or a related technical discipline.

• Experience with Python scripting, SQL queries, or related scripting languages for test development, automation, or data analysis.
• Experience with software test automation tools and frameworks, including integrating automated tests into CI/CD pipelines.
• Exposure to mobile application testing and other application software…