Medical Device Test Engineer (DXA Systems)

Our team develops world-class DXA bone densitometers. These medical devices must undergo rigorous testing prior to market release. We are seeking a Test Engineer to support product verification and validation activities, including the design, execution, and documentation of test processes for both new product development and cost improvement initiatives.

This role operates within a regulated medical device environment and requires strong hands-on testing experience across both software and hardware components.

Key Responsibilities

Testing & Validation

• Set up and configure test equipment and environments.

• Perform dry runs and execute formal Verification and Validation (V&V) activities using pre-defined test procedures.

• Execute system-level test protocols and usability test activities.

• Update and maintain Design Verification Test Procedures.

• Generate test result reports and support audit documentation.

Defect & Issue Management

• Investigate, document, and report defects and issues identified during testing.

• Support root cause analysis and verification of bug fixes.

• Record, track, and close defects throughout the testing lifecycle.

• Provide post-release application support and technical issue investigation.

Systems & Process Support

• Install, set up, and calibrate DXA/BMH devices under test.

• Collaborate with engineering teams on system improvements.

• Identify opportunities for process improvement and LEAN practices.

• Contribute to continuous improvement by incorporating industry best practices.

Qualifications

Required

• Bachelor’s degree in Computer Science, Engineering, or a STEM discipline.

• Minimum 2 years of experience in medical device testing.

• Experience in a regulated environment (FDA, ISO, IEC standards).

• Hands-on experience with:

  • Windows 10/11

  • SQL, MS Access

  • Requirements and test management tools (DOORS, Jama, or similar)

• Strong understanding of both software and hardware systems in embedded environments.

Preferred

• Prior experience with DXA systems.

• Familiarity with DOORS is highly desirable.

• Experience testing complex electromechanical or imaging systems.