IVD Laboratory Technician

CorDx; Alpharetta (GA); On-site; USD 70,000 - 110,000; Full time

Benefits offered by this job

Comprehensive medical insurance

401(k) plan with company contributions

Flexible paid time off (PTO) policy

Job summary

CorDx in Alpharetta, GA is seeking a biology-focused R&D professional to join our product design and development team. You will perform laboratory testing for lateral flow diagnostics, document results, and collaborate with R&D, Quality, and Regulatory teams to ensure ISO 13485 and 21 CFR Part 820 compliance.

The role requires a bachelor's degree in biology or related field, 2–3 years of IVD lab experience, and strong skills in data analysis, literature review, and experimental design.

Qualifications

• Bachelor's degree or higher in Biology, Medical Laboratory Science, Biotechnology, or a closely related field.
• Strong understanding of biological laboratory operations, experimental procedures, and common laboratory instruments.
• Proficiency in scientific literature search and interpretation.
• Familiarity with IVD product development processes and regulatory requirements (NMPA, FDA, IVDR) preferred.

Responsibilities

• Laboratory & Technical Responsibilities
• Perform laboratory testing and experimentation related to lateral flow diagnostic products, including assay preparation, testing, troubleshooting, and optimization
• Execute routine and non-routine testing to support product development, verification, validation, and performance evaluation
• Accurately document experimental procedures, observations, and results in laboratory notebooks, controlled forms, and electronic systems in compliance with quality system requirements
• Assist in reagent preparation, sample handling, equipment calibration, and laboratory maintenance
• Support various stages of the IVD product design and development process, 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 as required
• Execute testing activities in accordance with Evaluation Protocol (EP) documents for analytical and clinical performance evaluation
• Apply EPs to assess performance characteristics such as sensitivity, specificity, accuracy, precision, reproducibility, robustness, and stability
• Support data analysis and summary reporting for internal reviews, regulatory submissions, and design history file (DHF) documentation
• Follow Good Documentation Practices (GDP) and laboratory best practices
• Adhere to CorDx quality policies, SOPs, and safety requirements
• Participate in audits, inspections, and internal reviews as needed

Skills

Lab techniques

Data analysis

Scientific writing

Literature review

Education

Bachelor's degree in Biology or related field

Tools

Laboratory instruments

Job description

About Us

CorDx, 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.

About Us

CorDx, 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 Responsibilities

2. Product Design & Development Support

3. Evaluation Protocols & Performance Testing

4. Quality & Compliance

• Laboratory & Technical Responsibilities
• Perform laboratory testing and experimentation related to lateral flow (chromatographic) diagnostic products, including but not limited to assay preparation, testing, troubleshooting, and optimization
• Execute routine and non-routine testing to support product development, verification, validation, and performance evaluation
• Accurately document experimental procedures, observations, and results in laboratory notebooks, controlled forms, and electronic systems in compliance with quality system requirements
• Assist in reagent preparation, sample handling, equipment calibration, and laboratory maintenance
• Support various stages of the IVD product design and development process, 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 as required
• Execute testing activities in accordance with Evaluation Protocol (EP) documents for analytical and clinical performance evaluation
• Apply EPs to assess performance characteristics such as sensitivity, specificity, accuracy, precision, reproducibility, robustness, and stability
• Support data analysis and summary reporting for internal reviews, regulatory submissions, and design history file (DHF) documentation
• Follow Good Documentation Practices (GDP) and laboratory best practices
• Adhere to CorDx quality policies, standard operating procedures (SOPs), and safety requirements
• Participate in audits, inspections, and internal reviews as needed

Requirements

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.

Benefits

• Comprehensive medical insurance
• 401(k) plan with company contributions
• Flexible paid time off (PTO) policy