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Test Engineer – Medical Imaging & Device Validation

VITS Consulting

St. Paul, MN, MN

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JOB DETAILS
SALARY
$45–$55
SKILLS
Analysis Skills, Atlassian JIRA, Biomedical Engineering, Bug Tracking/Defect Management, Calibration, Communication Skills, Computed Tomography (CAT Scan), Computer Science, Continuous Improvement, Cross-Functional, Data Analysis, Design Verification, Digital Imaging and Communications in Medicine (DICOM), Documentation, Electrical Engineering, External Audit, FDA (Food and Drug Administration), FDA Requirements, Failure Mode and Effects Analysis (FMEA), Functional Testing, Hardware Components, Hardware Performance Testing, Hazard Analysis, Healthcare, Hewlett-Packard Product Family, ISO (International Organization for Standardization), Integration Testing, Internal Audit, International Electro-Technical Commission (IEC), Maintain Compliance, Medical Equipment, Medical Imaging, Medical Protocols, Medical Tests, Performance Metrics, Physics, Picture Archiving and Communication System (PACS), Presentation/Verbal Skills, Problem Solving Skills, Process Improvement, Product Lifecycle, Product Testing, Prototyping, Quality Assurance Methodology, Quality Engineering, Regression Testing, Regulatory Compliance, Risk Management, Root Cause Analysis, Safety/Work Safety, Software Engineering, Software Testing, System Integration (SI), System Test, System Validation, Systems Analysis, Systems Engineering, Systems Reliability, Team Player, Technical Writing, Test Automation, Test Case, Test Equipment, Test Plan/Schedule, Testing, Traceability, V&V Testing, Validation Testing, Writing Skills
LOCATION
St. Paul, MN, MN
POSTED
2 days ago
Test Engineer Medical Imaging & Device Validation
Location: St. Paul, MN (4 days/week onsite)
Job Type: Contract (12 months)
Position Overview
We are seeking a highly motivated Test Engineer to support the development, validation, and continuous improvement of Computed Tomography (CT) imaging systems and related medical device technologies. This role focuses on designing and executing verification and validation (V&V) testing activities for CT hardware, software, and integrated system components to ensure compliance with regulatory, quality, and performance requirements.
The ideal candidate will have experience in medical device testing, imaging systems, or other highly regulated environments, along with strong analytical, troubleshooting, and cross-functional collaboration skills.
Key Responsibilities
Test Development & Execution
  • Design, develop, and execute verification and validation (V&V) test protocols for CT imaging systems and subsystems.
  • Perform functional, integration, regression, and performance testing on CT hardware and software components.
  • Develop automated and manual test procedures to validate system reliability, safety, and image quality.
  • Conduct root cause analysis and troubleshooting for system failures and test anomalies.
System & Product Validation
  • Support testing activities throughout the product lifecycle, including prototype, design verification, validation, and sustaining engineering phases.
  • Validate CT imaging performance metrics such as image resolution, dose accuracy, reconstruction quality, and system calibration.
  • Collaborate with systems engineering, software engineering, electrical engineering, and quality teams to resolve technical issues.
Documentation & Compliance
  • Create and maintain detailed test plans, test cases, protocols, reports, and traceability documentation.
  • Ensure testing activities comply with FDA, ISO 13485, IEC 62304, IEC 60601, and other applicable medical device standards.
  • Support internal and external audits by providing testing documentation and technical rationale.
Continuous Improvement
  • Identify opportunities to improve testing efficiency, automation, and coverage.
  • Participate in risk management activities including FMEA and hazard analysis.
  • Contribute to process improvement initiatives within engineering and quality teams.
Required Qualifications
  • Bachelor's degree in Engineering, Computer Science, Biomedical Engineering, Electrical Engineering, or a related technical field.
  • 5+ years of experience in test engineering, quality engineering, or systems validation.
  • Experience working in regulated environments such as medical devices, healthcare technology, or imaging systems.
  • Strong understanding of system-level testing methodologies and defect tracking processes.
  • Experience with test equipment, diagnostic tools, and data analysis.
  • Strong troubleshooting and problem-solving abilities.
  • Excellent written and verbal communication skills.
Preferred Qualifications
  • Experience with CT imaging systems or other diagnostic imaging technologies.
  • Familiarity with DICOM, PACS, image reconstruction, or imaging workflows.
  • Experience with automated test frameworks and scripting languages such as Python, MATLAB, or LabVIEW.
  • Knowledge of FDA regulations and international medical device standards.
  • Understanding of radiation physics or imaging system calibration methodologies.
  • Experience using tools such as Jira, HP ALM, TestRail, or similar test management platforms.

About the Company

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VITS Consulting

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