IVD Laboratory Technician
About the job
- A bachelor's degree or higher in Biology, Medical Laboratory Science, Biotechnology, or a closely related field.
- A strong understanding of biological laboratory operations, experimental procedures, and common laboratory instruments.
- The ability to design experiments, perform data analysis, interpret results, and independently complete technical reports.
- Proficiency in scientific literature search and interpretation.
- Perform laboratory testing and experimentation related to lateral flow (chromatographic) diagnostic products, including assay preparation, testing, troubleshooting, and optimization.
- Execute routine and non-routine testing to support product development, verification, validation, and performance evaluation.
- Document experimental procedures, observations, and results in laboratory notebooks, controlled forms, and electronic systems in compliance with quality system requirements.
- Assist with reagent preparation, sample handling, equipment calibration, and laboratory maintenance.
- Support IVD product design and development from feasibility and prototyping through verification and validation.
- Collaborate 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.
- Execute testing in accordance with Evaluation Protocol (EP) documents for analytical and clinical performance evaluation.
- Apply Evaluation Protocols to assess sensitivity, specificity, accuracy, precision, reproducibility, robustness, and stability.
- Support data analysis and summary reporting for internal reviews, regulatory submissions, and design history file documentation.
- Follow Good Documentation Practices and laboratory best practices.
- Adhere to quality policies, standard operating procedures, and safety requirements.
- Participate in audits, inspections, and internal reviews as needed.
- A minimum of 2–3 years of laboratory or R&D experience in the IVD industry is preferred.
- Familiarity with IVD product development processes and regulatory requirements, including NMPA, FDA, and IVDR.
About the company
CorDx is a multinational biotech organization that provides rapid testing and point-of-care diagnostic devices. Its products are designed to quickly detect infectious diseases (like COVID-19), pregnancy, drugs of abuse, biomarkers, and other health indicators directly at the patient’s side. The devices work by offering fast diagnostic tests and wearable or handheld systems that deliver results on-site, often supported by data science and artificial intelligence to improve accuracy and capture health data. CorDx differentiates itself from competitors through its global reach (2,100+ employees in over 100 countries), scale, and its emphasis on integrating AI and data-driven insights to enhance diagnostic solutions. The company aims to help answer critical health questions by delivering practical, accessible diagnostics and moving toward personalized healthcare.
Company Size
51-200
Company Stage
N/A
Total Funding
N/A
Headquarters
Atlanta, Georgia
Founded
2006
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Simplify's Take
What believers are saying
- CorDx secured an FDA EUA for Tyfast Flu A/B and COVID-19 in 2024.
- The 2025 Singapore POCT Centre broadens access to infectious, fertility, and chronic-disease programs.
- CorDx opened a new Singapore facility in 2026, strengthening global manufacturing reach.
What critics are saying
- FDA authorization still governs key products like Tyfast and COVID-19 Ag under emergency use.
- Singapore expansion raises fixed costs while diagnostics demand remains volatile after pandemic-era normalization.
- Any U.S. FDA or EU IVDR setback would strand CorDx's multiplex-test commercialization roadmap.
What makes CorDx unique
- CorDx spans R&D, manufacturing, and supply chain across the U.S., China, and Singapore.
- The 2025 DxD Hub POCT Centre deepens CorDx's Singapore diagnostics collaboration.
- MasterControl adoption signals a compliance-first operating model across global quality and manufacturing systems.
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Benefits
- Health Insurance
- Dental Insurance
- Vision Insurance
- Training Programs
- Paid Vacation
- 401(k) Retirement Plan
- Meal Benefits