Software Test Engineer II

Software Test Engineer II

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.

Responsibilities

• 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.

Required Qualifications

• 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.

Preferred Qualifications

• 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.

Ideal Backgrounds

Candidates may come from roles such as:

• Software Verification Engineer
• Validation Engineer
• Software Test Engineer
• Test Automation Engineer
• Systems Test Engineer
• Software Quality Engineer
• Design Assurance Engineer
• Product Verification Engineer

Experience within medical devices, healthcare technology, life sciences, diagnostics, imaging systems, connected devices, capital equipment, or other regulated industries is highly preferred.

What Makes This Opportunity Unique

• Work on products that directly impact patient care.
• Exposure to complex software and hardware integrated systems.
• Opportunity to influence software quality, automation, cybersecurity, and product reliability.
• Collaborative engineering environment with strong cross-functional engagement.
• Long-term consulting engagement supporting multiple product initiatives.
• Visibility across a broad portfolio of innovative healthcare technologies.

Keywords

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.

Desired Skills and Experience Software Verification & Validation (V&V) Software Test Automation Python PyTest Systems Testing Design Verification Validation Testing Requirements Traceability Risk-Based Verification Medical Device Software FDA-Regulated Environment IEC 62304 ISO 1

EOE Statement: Specialist Staffing Group is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

To find out more about Real, please visit www.realstaffing.com