QA & Testing Engineer

Echopixel - Santa Clara, CA

Full-time

Santa Clara, CA

Administrative and Support Services

About the position

We are looking for a motivated Quality Assurance (QA) and Testing engineer to preside over our software testing ecosystem - developing and executing exploratory and automated tests to ensure product quality and compliance with applicable regulatory standards. The QA/Test engineer will play a vital role in our company's product development cycle. Our ideal candidate will be responsible for designing, writing, and implementing tests in a regulated medical device environment, as well as documenting, reporting, and helping to resolve software defects. You will also be responsible for writing, reviewing, and refining software requirements, and ensuring that released software products meet customer and regulatory requirements. If you'd like to be on the bleeding edge of medical technological innovation and have a passion for quality assurance, we'd love to hear from you!

Responsibilities

• Translate software requirements / functional specifications into effective test cases while ensuring consistency with regulated protocols
• Execute test cases and effectively compile, document, and analyze test results to assess product quality
• Identify, document, and track defects through automated and exploratory testing and work with developers to resolve those defects
• Prioritize and coordinate testing activities, including functional, system, and regression testing
• Design and develop automated tests and testing strategies
• Prepare and maintain test data
• Ensure that all validation activities and customer deliverables meet regulatory guidelines
• Provide recommendations and guidance in best practices and tooling for QA infrastructure

Requirements

• A minimum of two years relevant experience in a medical device structured software development environment
• Bachelor's / Master's degree (preferably computer science or a related field)
• Experience writing formal verification and validation tests in a FDA-regulated environment
• Experience prioritizing, planning, and coordinating full testing life-cycles
• Excellent oral and written communications skills
• Excellent organizational skills
• Analytical mind and problem-solving aptitude and attention to detail

Nice-to-haves

• Experience with defect tracking / management tools
• Experience with automation software tools and scripting (Selenium, Ranorex, etc.)
• Hands-on experience with Agile projects
• Familiarity with US 21 CFR 820, 21 CFR Part 11 and ISO 62304 requirements
• Experience implementing DevOps and Continuous Integration