Medical Device Test Engineer

Conflux Systems, Inc.

Newton, MA

JOB DETAILS
SALARY
$45
SKILLS
Biomedical Engineering, Continuous Improvement, Documentation, Electrical Engineering, Electromechanical Systems, Electromechanics, International Electro-Technical Commission (IEC), Mechanical Engineering, Medical Equipment, Medical Protocols, Medical Robotics, Medical Tests, Product Testing, Quality Assurance Methodology, Requirements Validation/Verification, Risk Management, Robotics Software, Software Engineering, Software Validation, Statistics, Strategic Planning, System Test, Systems Engineering, Test Fixtures, Test Plan/Schedule, Testing, Traceability, Validation Testing, Verification Engineering
LOCATION
Newton, MA
POSTED
30+ days ago

We are seeking a Contract System Test Engineer to support verification activities for a complex medical robotics system used in advanced robotic-assisted vascular interventions. The role focuses on developing and executing system-level testing, ensuring product requirements traceability, and supporting verification and validation for complex electromechanical medical devices. The ideal candidate will contribute to quality processes, implement verification methods, and support continuous improvement across systems engineering and testing workflows.

Responsibilities:

  • Develop and implement test methods for verification of complex medical robotic systems.

  • Execute system and subsystem verification testing during verification and validation (V&V) phases.

  • Maintain and update requirements traceability and risk management documentation.

  • Implement processes within verification and issue management toolchains.

  • Perform statistical analysis and determine sample size for tests using statistical methods.

  • Validate software tools and test fixtures used in testing activities.

  • Support continuous improvement of systems engineering and quality processes.

Qualifications:

  • Bachelor’s degree in Systems Engineering, Biomedical Engineering, Robotics, Software Engineering, Mechanical Engineering, or Electrical Engineering.

  • 5+ years of experience in medical device testing, preferably with medical or surgical robotics systems.

  • Strong knowledge of verification strategy development, test method validation, and requirements traceability.

  • Experience with IEC 60601-1 and related medical device standards.

  • Background in electromechanical systems testing, statistical test analysis, and verification toolchain implementation.

  • Experience supporting complex medical device programs through verification and validation phases.

About the Company

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Conflux Systems, Inc.