Software Test Engineer II
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Role details
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Job description
Our client, a global leader in medical technology, is seeking a Software Verification & Test Automation Engineer to support the development, verification, and release of complex medical device platforms used in patient-care environments worldwide.
This consultant will work within a multidisciplinary engineering organization responsible for ensuring the safety, quality, cybersecurity, and reliability of software-driven medical products. The ideal candidate combines strong software verification expertise with an understanding of regulated product development and system-level testing.
This is an excellent opportunity for engineers who enjoy working at the intersection of software, hardware, quality, and patient safety while contributing to products that have a direct impact on healthcare outcomes., * Execute software verification and validation activities throughout the product development lifecycle.
- Develop, maintain, and enhance automated test frameworks and test scripts using Python and other automation tools.
- Create and execute verification protocols, test plans, and test cases based on product requirements.
- Support requirements traceability and ensure verification activities align with applicable quality and regulatory standards.
- Perform functional, integration, regression, system-level, and end-to-end testing.
- Investigate software defects, perform root-cause analysis, and work closely with development teams to drive resolution.
- Collaborate with Systems, Software, Quality, Regulatory, and Product Engineering teams to ensure successful product releases.
- Contribute to technical documentation including verification reports, risk-based testing documentation, and design history file deliverables.
- Support cybersecurity verification and testing activities on connected medical device products.
- Participate in sustaining engineering efforts, product updates, and continuous improvement initiatives., Software Verification * Validation * V&V * Medical Devices * Test Automation * Python * PyTest * Systems Testing * Design Verification * Requirements Traceability * Cybersecurity Testing * Risk-Based Verification * DHF Documentation * Hardware/Software Integration * Windows-Based Systems * FDA-Regulated Products * Quality Engineering * CI/CD * Product Development * Sustaining Engineering
This version is intentionally client-anonymous while still being specific enough to attract the exact type of E2/E3 medical device software verification and automation engineers that are most likely to succeed on the engagement.
Requirements
- Bachelor’s degree in Computer Engineering, Software Engineering, Electrical Engineering, Biomedical Engineering, or related technical field.
- Experience supporting FDA-regulated or highly regulated product development environments.
- Experience performing software verification and validation (V&V).
- Understanding of requirements-based testing and requirements traceability.
- Experience developing or maintaining automated test solutions.
- Strong problem-solving and troubleshooting abilities.
- Excellent written and verbal communication skills.
- Ability to work effectively within cross-functional engineering teams., * Medical device industry experience.
- Python-based test automation experience.
- Experience with PyTest, Selenium, Robot Framework, or comparable automation tools.
- Familiarity with risk-based verification methodologies.
- Knowledge of software lifecycle standards and quality systems.
- Experience generating test protocols, reports, and verification documentation.
- Background supporting hardware/software integrated systems.
- Cybersecurity testing or product security validation experience.
- Experience working in Windows-based product environments.
- Knowledge of CI/CD tools and automated testing workflows., Experience within medical devices, healthcare technology, life sciences, diagnostics, imaging systems, connected devices, capital equipment, or other regulated industries is highly preferred.
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