IVD Laboratory Technician

About UsCorDx, a multi-national biotech organization, focused on pushing the limits of innovation and supply in global health. With over 2000 employees across the world serving millions of users in over 100 countries, CorDx delivers rapid testing and point-of-care medical device solutions used in the detection of infectious diseases such as COVID-19, pregnancy, drug abuse, biomarkers, and more. CorDx is at the cutting edge of technology, artificial intelligence, and data science with the goal of delivering diagnostic solutions to some of the most critical questions in healthcare.Key Responsibilities2. Product Design & Development Support3. Evaluation Protocols & Performance Testing4. Quality & Compliance Laboratory & Technical ResponsibilitiesPerform laboratory testing and experimentation related to lateral flow (chromatographic) diagnostic products, including but not limited to assay preparation, testing, troubleshooting, and optimizationExecute routine and non-routine testing to support product development, verification, validation, and performance evaluationAccurately document experimental procedures, observations, and results in laboratory notebooks, controlled forms, and electronic systems in compliance with quality system requirementsAssist in reagent preparation, sample handling, equipment calibration, and laboratory maintenanceSupport various stages of the IVD product design and development process, from feasibility and prototyping through verification and validationCollaborate with R&D, Quality, and Regulatory teams to ensure development activities comply with applicable sections of ISO 13485 and 21 CFR Part 820 (Quality System Regulation)Contribute to design inputs, design outputs, risk management activities, and design change documentation as requiredExecute testing activities in accordance with Evaluation Protocol (EP) documents for analytical and clinical performance evaluationApply EPs to assess performance characteristics such as sensitivity, specificity, accuracy, precision, reproducibility, robustness, and stabilitySupport data analysis and summary reporting for internal reviews, regulatory submissions, and design history file (DHF) documentationFollow Good Documentation Practices (GDP) and laboratory best practicesAdhere to CorDx quality policies, standard operating procedures (SOPs), and safety requirementsParticipate in audits, inspections, and internal reviews as neededRequirements Education Bachelor's degree or higher in Biology, Medical Laboratory Science, Biotechnology, or a closely related field. Technical Skills Strong understanding of biological laboratory operations, experimental procedures, and common laboratory instruments. Ability to design experiments, perform data analysis, interpret results, and independently complete technical reports. Proficiency in scientific literature search and interpretation. Familiarity with IVD product development processes and regulatory requirements (NMPA, FDA, IVDR) preferred. Experience Minimum of 2-3 years of laboratory or R&D experience in the IVD industry preferred. BenefitsComprehensive medical insurance401(k) plan with company contributionsFlexible paid time off (PTO) policy