Senior Software Test Engineer

Overview

The Senior Software Test Engineer will lead and execute verification and validation (V&V) activities for software components and systems within a Class II medical device. This includes embedded software, application software, and system integration testing.

The position ensures compliance with FDA 21 CFR 820.30, ISO 13485, IEC 62304, and ISO 14971 by developing test strategies, designing test cases, executing tests, analyzing results, and mentoring junior test engineers.

This role requires a strong combination of technical depth, regulatory understanding, and leadership in quality-driven testing practices.

• Lead the definition and execution of Software Verification and Validation (V&V) strategies for Class II medical devices.
• Develop and review test plans, protocols, and reports ensuring coverage of software requirements, risk mitigations, and regulatory expectations.
• Participate in software risk analysis, identifying test requirements based on hazard mitigations and system interfaces.
• Maintain traceability matrices between requirements, risk controls, and test cases within ALM tools (e.g., Polarion, Jama, Ketryx, Helix ALM, or Jira).

• Design and execute manual and automated test cases for embedded, application, and integration-level testing.
• Perform functional, regression, system, interface, and performance testing across software layers (UI, middleware, embedded, host-PC).
• Develop and maintain test automation frameworks or scripts (Python, Robot Framework, C#, or equivalent).
• Conduct data integrity, safety, and error-handling testing in alignment with risk controls.
• Lead test result analysis, defect investigation, and root cause reviews in collaboration with development teams.
• Verify that software meets intended use, usability, and reliability requirements prior to release.

• Ensure all testing complies with IEC 62304 (software lifecycle), FDA 21 CFR 820.30 (Design Controls), and ISO 13485 documentation requirements.
• Generate and maintain test method validation (TMV) documentation where applicable.
• Ensure Good Documentation Practices (GDP) in all testing artifacts.
• Support regulatory submissions (e.g., 510(k), MDR) by providing validated test data, traceability matrices, and verification summaries.
• Participate in internal and external audits by demonstrating compliance with V&V and QMS procedures.

• Mentor and train junior software test engineers on compliant test methodologies, traceability, and automation tools.
• Act as a technical lead for one or more software components or subsystems.
• Provide input to improve test processes, templates, and automation strategies.
• Collaborate cross-functionally with Development, Systems Engineering, Quality, and Regulatory Affairs to align on testing expectations and deliverables.

Education:

• Bachelor’s or Master’s degree in Computer Science, Software Engineering, Biomedical Engineering, or a related technical field.

Experience:

• 6–10 years of experience in software verification and validation, with at least 3 years in the medical device industry (Class II or higher).
• Demonstrated experience with FDA-regulated and ISO 13485-compliant environments.
• Hands-on experience with requirements-based testing, risk-based verification, and traceability management.
• Proven ability to design, execute, and automate test cases for complex embedded and application-level systems.
• Familiarity with ALM and defect-tracking tools (e.g., Jira, Azure Dev Ops, Polarion, Ketryx).

Technical

Competencies:

• Deep knowledge of IEC 62304, ISO 14971, and FDA design control requirements.
• Experience in testing embedded firmware, GUI applications, or device-host communication interfaces.
• Working knowledge of test automation (Python, Robot Framework, PyTest, or C# frameworks).
• Proficiency with version control (Git), CI/CD pipelines (Jenkins, Git Lab CI), and test data analysis.
• Understanding of cybersecurity, interoperability, and data privacy testing for medical devices.

Soft Skills:

• Strong analytical and problem-solving mindset.
• Excellent documentation and communication skills in a regulated environment.
• Ability to lead test activities, prioritize tasks, and meet deadlines under quality constraints.
• Collaborative and adaptable — effective across software, systems, and quality teams.
• Attention to detail and commitment to continuous process improvement.

Preferred Qualifications:

• Experience testing catheter-based imaging, diagnostic, or therapeutic medical systems.
• Experience supporting 510(k) or EU MDR software documentation packages.
• Familiarity with cybersecurity risk assessment and penetration testing coordination.
• Knowledge of cloud-connected medical software or AI/ML-based diagnostic algorithms.
• ISTQB Advanced, ASQ CSQE, or Six Sigma Green Belt certification.

Example Deliverables:

• Software V&V Plan and Protocols
• Test Cases, Results, and Reports
• Traceability Matrix (Requirements ? Tests ? Risks)
• Test Automation Scripts
• Software…