Cordx
IVD Laboratory Technician
Alpharetta, Georgia, United States
Sponsorship not specifiedDetected 201 days ago
Data AnalysisData ScienceA/B TestingLoad TestingClinical Laboratory TechniquesFDA RegulatoryMedical Devices
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Cap-exempt (no lottery)0
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Entry-level history0
PERM / green-card track0
Lottery odds40
Fits your clock70
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About the role
- 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.
- Assist in reagent preparation, sample handling, equipment calibration, and laboratory maintenance.
- Apply EPs to assess performance characteristics such as sensitivity, specificity, accuracy, precision, reproducibility, robustness, and stability.
Responsibilities
- 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.
- Product Design & Development Support 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).
- Evaluation Protocols & Performance Testing 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.
- Ability to design experiments, perform data analysis, interpret results, and independently complete technical reports.
Requirements
- Contribute to design inputs, design outputs, risk management activities, and design change documentation as required.
- Technical Skills Strong understanding of biological laboratory operations, experimental procedures, and common laboratory instruments.
Skills
- 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.
- Experience Minimum of 2-3 years of laboratory or R&D experience in the IVD industry preferred.
- Comprehensive medical insurance.
- 401(k) plan with company contributions.
- Flexible paid time off (PTO) policy.
Benefits
- About Us CorDx, a multi-national biotech organization, focused on pushing the limits of innovation and supply in global health.
- Education Bachelor's degree or higher in Biology, Medical Laboratory Science, Biotechnology, or a closely related field.
Company info
- 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.
This listing is sourced directly from Cordx's careers page and normalized into a canonical job model.