Test Engineer

Test Engineer – MedicalDevices (R&D / Design Verification)We are seeking a Test Engineer to support R&D product development for disposable medical devices. This role focuses on translating design requirements into structured testing solutions that ensure product safety, performance, and regulatory compliance. Key ResponsibilitiesDevelop and execute test plans, protocols, and procedures based on product design requirements Design and validate test methods for medical device components and systems Perform hands-on laboratory testing, prototype evaluation, and data analysis Ensure testing aligns with FDA Quality System Regulations, ISO 13485, and CE requirements Analyze test data and recommend improvements to design, processes, or test methods Maintain lab equipment, calibration records, and test fixtures. Collaborate with R&D engineers, suppliers, and cross-functional teams Prepare clear technical reports and presentations on test outcomes Required Skills & QualificationsBachelor’s degree in Mechanical, Biomedical, Materials Engineering, or related field 0–4 years of experience in medical device testing or regulated R&D environment Strong understanding of test development, verification, and validation Hands-on experience with lab equipment such as: Instron tensile testers Microscopes Basic mechanical and material testing tools Proficiency in: Microsoft Excel, Word, PowerPoint Minitab (or similar statistical tools) Strong problem-solving, documentation, and communication skills Preferred ExperienceExposure to FDA / ISO 13485 regulated environmentsExperience in test fixture design or prototype testing Familiarity with SolidWorks, AutoCAD, or eDrawings Prior work in medical device R&D or product development labs What We’re Looking ForA detail-oriented, hands-on engineer who enjoys lab-based problem solving, working with prototypes, and ensuring products meet the highest standards of quality and compliance.