Biomedical Testing Validation Intern
Quanta Dialysis Technologies, United States
Job Description
Quanta Dialysis Technologies is a medical device company headquartered in the UK with US operations based in Beverly, MA. We are seeking a highly motivated and detail orientated individual to join our team as a Biomedical Testing amp; Validation Intern. As an intern you will have the opportunity to gain hands-on experience in testing and evaluating medical devices, ensuring their safety, reliability, and compliance with regulatory standards. This internship provides an opportunity to work in a dynamic start-up environment while contributing to the development of life-saving medical devices.
The role will involve conducting extensive test requirements relating to QDT Dialysis device viability, as directed by Sr. Operations Manager. The role directly supports the Repair amp; Maintenance team by performing rigorous consecutive treatment testing post upgrade amp; pre-shipment to ensure effective field performance post installation. The role may also require maintaining the hot swap pool in the cell under the direction of the Ramp;M team.
This is a paid internship running from June through August based on-site at our Beverly, MA location.
Key Responsibilities
- Assist in the execution of testing protocols for medical devices, following established procedures and guidelines.
- Perform various testing procedures, including functionality, performance, safety, and reliability tests, according to specific testing plans and project requirements.
- Collect and analyze data generated during testing, accurately recording observations, measurements, and test results.
- Identify and report any deviations, inconsistencies, or abnormalities observed during testing, promptly notifying the supervisor or relevant team members.
- Collaborate with engineers and other team members to troubleshoot and resolve technical issues encountered during testing.
- Maintain and calibrate testing equipment and instruments, ensuring they are in proper working condition and adhering to quality standards.
QDT Dialysis Device Test Execution
- Executing of tests to meet required timelines.
- Reporting of test(s) status and agreed project metrics in accordance with agreed timescales.
- Writing of test reports that accurately report test outcomes.
- Accurate reporting and escalation of problems where required through the correct channels as per company processes to enable prompt resolution.
- Timely completion of allocated tests as evidenced by defined project metrics.
- Maintain a training record and identify training needs to the relevant individual (manager or HR).
- Ensure that all documents and actions performed adhere to the Quality Management System and related WI’s/OP’s.
Repair and Maintenance Cell
- Maintain the hot swap pool, completing hot rinses and other associated actions to ensure the pool is maximized to the required standards.
- Movement of machines for deployment, including packaging and recording through defined processes.
- Ensure that all U/S parts are disposed of correctly using WEEE or associated requirements.
- Maintain GMP compliant work areas at all times for all areas relating to the Operations areas.
Requirements
- Ability to work in a technical/engineering related role where capturing and processing data is a key task, with proven ability to follow basic technical and engineering instructions.
- Currently pursuing a degree in Biomedical Engineering, Electrical Engineering, Mechanical Engineering, or a related field.
- Strong interest in the medical device industry and a desire to contribute to the development of innovative healthcare technologies.
- Basic knowledge of medical device testing principles and methodologies.
- Able and willing to work as part of a team, with strong verbal and written communication skills for writing reports and escalating issues.
- Strong MS Office skills including Excel
- Knowledge or previous experience of the medical industry and related quality standards (e.g. ISO13485) is desired but not essential.