Test Engineer

Test Engineer

The Test Engineer designs, builds, and validates test methods for verification and validation testing for medical devices and disposables in an ISO 13485 and FDA QSR compliant environment. This role reports to Quality or Engineering Management, supporting various project teams in different stages of project maturity from R&D through Production.

Key Responsibilities

• Verification Testing:
  Plan and execute Design Verification and Validation activities for complex electromechanical devices and single-use disposables
• Test Method Development:
  Design, develop, validate and execute test methods to inform design decisions and verify system functionality
• Research & Development:
  Conduct early-stage exploratory testing and characterization to support design inputs
• Equipment Development:
  Design, fabricate, and assemble custom test fixtures and automated equipment
• Equipment Validation:
  Write and execute protocols and reports for test software and hardware
• Documentation:
  Author test protocols, data sheets, and final reports. Author/assist manufacturing procedures, machine instructions
• Quality Compliance:
  Ensure all activities align with ISO 13485, FDA 21 CFR Part 820, and risk management standards
• Data Analysis:
  Apply statistical techniques like ANOVA, Gage R&R, and capability analysis to test datasets
• Communication:
  Present test findings to relevant stakeholders, communicate risk and countermeasure insights as applicable

Required Qualifications

• Education:
  
  Bachelor's degree in Mechanical, Electrical, Biomedical, or Quality Engineering, or 3-4 additional years of trade experience
• Experience:
  
  2–5 years of engineering experience within the medical device or regulated industry
• Regulations:
  Working knowledge of ISO 13485, FDA QSR, and ISO 14971 risk management standards
• Verification & Validation:
  Direct experience in planning and execution of Verification and Validation for complex electrotechnical devices
• Validation
  
  Skills:
  
  Direct experience writing and executing Equipment IQ/OQ/PQ and Test Method Validation (TMV)
• Technical Tools:
  Proficiency with data acquisition systems, and proficiency in analysis tools like MATLAB, or statistical software like Minitab
• Lab
  
  Skills:
  
  Hands-on experience using mechanical test equipment like tensile testers, gauges, and sensors

Preferred Qualifications

• Experience with endoscopic surgical laser systems
• Experience with surgical fluid irrigation/aspiration systems and components (pumps, pressure sensors, flow sensors)
• Experience testing polymer-based fluid delivery components or single-use medical disposables (biocompatibility, sterilization validation)
• Solid Works or CAD proficiency for mechanical fixture design
• Experience coding data acquisition using Python / C, able to troubleshoot basic code
• Able to read schematics
• Experience with rapid prototyping (SLA, FDM, CNC)