Qualitest is seeking a Verification Engineer II to ensure medical device systems meet industry regulations and safety standards, contributing to patient safety and product excellence.
Requirements
- 2+ years of experience in medical device design verification or a related engineering field.
- Proficient in the V-model, requirements traceability matrix, and formal protocol writing.
- Strong analytical, troubleshooting, and problem-solving skills.
- Front-end: HTML, CSS, JavaScript, and frameworks such as React, Angular, or Vue.js.
- Back-end: Experience with Node.js, Python, Java, Ruby, PHP, or .NET.
- Database experience with both SQL (MySQL, PostgreSQL) and NoSQL (MongoDB) systems.
- Familiarity with RESTful APIs, microservices, and third-party integrations.
Responsibilities
- Actively participate in requirements engineering, including creation and review of product requirements.
- Develop and execute formal test protocols in compliance with IEC 60601-1, IEC 62304, and other relevant medical standards.
- Perform statistical sample size calculations and analyze test data to ensure regulatory compliance.
- Design and develop test methods and fixtures for verification testing.
- Document test reports, maintain defect logs, and investigate testing anomalies.
- Troubleshoot and resolve issues arising during the testing lifecycle.
Other
- Bachelor’s degree in Computer Science, Engineering, or a related technical field (or equivalent practical experience).
- Experience using version control systems like Git.
- Excellent communication and collaboration skills.
- Experience with cloud platforms: AWS, Azure, or Google Cloud.
- Knowledge of containerization/orchestration tools such as Docker and Kubernetes.
