Clinical Validation Specialist
About The Position
As a Clinical Validation Engineer at Circadia, you will support the validation of next-generation medical device technology in both laboratory and real-world clinical environments. Your primary responsibility will be the execution of clinical studies and verification testing. Following an onboarding and training period, you will be expected to independently execute clinical study data collection and perform verification tests in accordance with approved protocols and quality standards. Over time, and depending on interest and demonstrated capability, the role offers exposure to study design, regulatory documentation, publication in scientific journals, and/or development of test systems. This is a hands-on role at the interface of medical device engineering, clinical research, and quality systems.
Requirements
- Bachelor’s or Master’s degree in Biomedical Engineering, Biomedical Sciences, Neuroscience, or related field
- 1 - 3 years of relevant industry experience in medical device, research, or clinical research preferred
- Prior hands-on experience with instrumentation or physiological monitoring systems
- Willingness to travel to clinical sites as required
- Physical Requirements/Work Environment
- This position involves regular field-based research activities in clinical environments. The role requires the ability to:
- Travel to healthcare facilities, skilled nursing facilities, hospitals, and patient homes throughout California.
- Travel to research sites outside of California as needed, including commercial air travel.
- Transport and carry research equipment weighing up to 35 pounds.
- Load, unload, and set up monitoring equipment at study locations.
- Stand for extended periods during study procedures and device setup.
- Bend, reach, and position monitoring equipment on patients in clinical and residential environments.
- Work in a variety of healthcare settings, including patient rooms and long-term care facilities.
- A valid driver’s license and ability to travel independently to research sites are required.
Responsibilities
- Clinical Study Execution - Execute clinical validation studies in nursing facilities, home health settings, and other care settings
- Support participant recruitment and informed consent processes
- Prepare and operate investigational and reference devices
- Apply physiological sensors and ensure proper data capture
- Troubleshoot device and data acquisition issues during study sessions
- Maintain accurate source documentation and data recordsEnsure protocol adherence and data integrity
- Work in accordance with internal quality procedures and Good Clinical Practice (GCP) principles
- Following initial training, you will independently run study sessions in coordination with the research team, and learn how medical device clinical validation studies are conducted.
- Verification & Test Execution - Collaborate with engineering teams to design and execute structured verification and validation test plans
- Assemble, calibrate, and maintain laboratory test setups
- Perform controlled performance testing of sensor and device systems
- Perform field testing experiments, in healthcare facilities and patient homes
- Collect, organize, and document test data
- Contribute to data analysis, interpretation, and reporting
- Contribute to test reports in compliance with internal quality procedures
- You will develop the ability to independently execute device test protocols, resolve technical issues, and learn to design medical device verification protocols.
- Depending on experience and interest, the role may expand to include:
- Contributing to study protocol development and experimental design
- Supporting regulatory documentation within the quality management system
- Assisting in preparation of verification reports and study summaries
- Contributing to development of internal data collection tools and experimental setups
- Supporting literature reviews
- Supporting data analysis, interpretation, and reporting
- Contributing to publications of research findings in white papers and peer-reviewed journals
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
