Software Test Engineer

This role focuses on executing system-level software verification activities for a regulated medical device platform. The software test engineer writes and executes formal test scripts, installs and validates software builds on target hardware, performs verification testing, and generates compliant verification documentation for Design History File (DHF) records. Approximately 70% of the role involves hands-on test execution, while about 30% centers on technical documentation and verification reporting. The position requires independently authoring test protocols, executing formal verification activities, and producing audit-ready documentation within a regulated product development environment. The role offers the opportunity to work on software used in critical patient-care environments, directly impacting quality, safety, and regulatory compliance, while gaining exposure to the full verification lifecycle and FDA-regulated development practices. Responsibilities

• Author system-level verification test scripts and protocols using Application Lifecycle Management (ALM) based processes.
• Install and configure software releases on designated embedded hardware platforms.
• Execute scripted verification testing to confirm system behavior against defined requirements.
• Perform exploratory verification testing to identify unexpected behaviors and edge cases.
• Conduct dry runs prior to formal verification testing to validate test readiness and coverage.
• Perform formal verification execution against documented system and software requirements.
• Identify, document, and track defects discovered during testing using established defect management processes.
• Maintain end-to-end traceability between requirements, test cases, and test results within ALM tools.
• Collaborate closely with software engineers to clarify expected system behavior and ensure adequate test coverage.
• Author Verification Review Records (VRRs) and other verification documentation in accordance with regulated processes.
• Generate verification summaries and traceability reports that support regulatory and quality requirements.
• Document test evidence, including logs, screenshots, and results, to ensure DHF compliance.
• Route completed verification packages through formal document approval workflows (such as TcU processes).
• Support audit readiness by ensuring verification documentation is complete, consistent, and audit-ready.
• Contribute to continuous improvement of verification processes, documentation practices, and test coverage.
• Engage with engineering, quality, and regulatory stakeholders to ensure alignment on verification strategy and outcomes.

Auditing Visionary Innovation Reliability Traceability Unit Testing Collaboration Detail Oriented Medical Devices Computer Science Software Systems Embedded Systems Software Testing Transitional Care Defect Management Workflow Management Formal Verification Software Engineering Regulatory Compliance Test Execution Engine Biomedical Engineering New Product Development Technical Documentation Engineering Design Process C++ (Programming Language) Verification And Validation Continuous Improvement Process Application Lifecycle Management

At least 2 years, * Bachelor’s degree in Engineering, Computer Science, Biomedical Engineering, Software Engineering, or a related technical discipline.

• Minimum of 2 years of relevant experience in software testing, verification, or related technical roles.
• Experience writing test scripts, preferably for medical device or other regulated software systems.
• Hands-on experience authoring technical documents such as verification reports, beyond simple formatting tasks.
• Comfort working within a regulated Design History File (DHF) documentation process.
• Ability to author system-level verification test scripts and protocols using ALM-based processes.
• Proficiency in executing scripted and exploratory verification testing on embedded or system-level platforms.
• Experience identifying, documenting, and tracking software defects during verification activities.
• Familiarity with maintaining traceability between requirements, test cases, and test results.
• Strong attention to detail and ability to produce audit-ready documentation in a regulated environment.
• Effective collaboration skills for working with software engineers and cross-functional teams.

Additional Skills & Qualifications

• Experience with C++ and Google Test for unit test support.
• Exposure to PrisMax or similar embedded medical device platforms.
• Familiarity with ALM and DOORS tools for requirements and test management.
• Experience in verification and validation (V&V) testing for regulated products.
• Background in medical device software testing or other safety-critical systems.
• Experience authoring verification review records, verification summaries, and traceability reports.
• Understanding of FDA-regulated development environments and design control processes.
• Interest in working on software used in critical patient-care environments and contributing to patient safety., Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors.

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