Test Engineer

The Test Engineer supports R&D for disposable medical devices by developing and executing test strategies aligned with product requirements. This is a hands-on engineering role focused on test method development, data analysis, and validation activities within regulated environments., * Develop, design, and execute test plans, protocols, and procedures to evaluate product performance against specifications

• Translate design requirements into testing solutions considering technical, cost, and schedule constraints
• Perform data analysis, document results, and recommend improvements to test methods, processes, or equipment
• Support prototype and product testing, including test fixture design and setup
• Coordinate testing activities (lab space, equipment, vendors, timelines)
• Maintain R&D lab operations, including calibration records and preventive maintenance
• Ensure compliance with FDA Quality System Regulations, ISO standards, and CE Marking requirements
• Apply statistical methods and experimental design principles where applicable
• Communicate findings via technical reports, presentations, and cross-functional collaboration
• Interface with engineering teams, suppliers, and stakeholders to support development goals

• Bachelor's degree in engineering (Mechanical, Biomedical, Materials, or related field preferred)
• Minimum 2 years of engineering experience
• Strong hands-on execution and troubleshooting skills
• Experience with SolidWorks or similar CAD tools
• Knowledge of product testing and validation processes, * Experience in medical device development under FDA regulations
• Exposure to statistical analysis / Design of Experiments (DOE)
• Experience working in a machine shop or machining environment

Technical Skills

• Lab equipment: microscopes, Instron testers, vibration/noise analyzers, etc.
• Tools: Microsoft Office (Excel, Word, PowerPoint), Minitab
• CAD: SolidWorks, AutoCAD, eDrawings

Core Competencies

• Strong analytical and problem-solving ability
• Clear written and verbal communication
• Ability to work independently and collaboratively
• Effective project coordination and time management