Test Engineer

Position Summary

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 com plex 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