IVD Laboratory Technician

Key Responsibilities

• Perform laboratory testing and experimentation related to lateral flow (chromatographic) diagnostic products.
• 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.
• 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.
• 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.