Description

Key Responsibilities

• Design and develop comprehensive test strategies, plans, and test cases for complex medical device systems
• Execute and oversee functional, integration, system-level, and performance testing
• Lead verification and validation (V&V) activities in alignment with regulatory and quality standards
• Perform root cause analysis on defects and collaborate with cross-functional teams on resolution efforts
• Review requirements and system architecture to ensure strong test coverage and product reliability
• Develop test reports, traceability matrices, and validation documentation

Automation & Framework Development

• Design, develop, and maintain scalable automated test frameworks and infrastructure
• Build automated test scripts using Python, C/C++, or similar programming languages
• Integrate automated testing into CI/CD pipelines to support continuous validation
• Improve test efficiency, reliability, and coverage through automation and tooling enhancements
• Evaluate and implement new tools and technologies to strengthen testing capabilities

Cross-Functional Collaboration

• Partner with software, hardware, systems, and quality teams to define testing strategies and quality objectives
• Support system integration, product bring-up, and troubleshooting activities
• Collaborate with manufacturing and field teams on failure analysis and issue resolution
• Mentor junior engineers and contribute technical leadership on testing methodologies and best practices

Minimum Qualifications

• Bachelor’s or Master’s degree in Electrical Engineering, Computer Engineering, Computer Science, Biomedical Engineering, or related field
• 3+ years of experience in medical device testing, system validation, or software quality engineering
• Strong understanding of system-level testing across hardware, software, and integrated systems
• Experience with automation frameworks and scripting languages such as Python or C/C++
• Knowledge of verification & validation processes and defect tracking systems
• Hands-on experience with lab equipment and system-level debugging
• Strong analytical, troubleshooting, and problem-solving skills

Preferred Qualifications

• Experience working within regulated medical device environments
• Background in Agile/Scrum development methodologies
• Experience with CI/CD systems and automated test pipelines
• Familiarity with Linux/Unix environments
• Experience supporting both hardware and software testing efforts
• Prior mentoring or technical leadership experience

Key Skills

Education

Bachelor's or Master's degrees