SetPoint Medical is seeking an experienced, high caliber Document Control Specialist to own the process for ensuring all company-wide controlled documentation and records in the quality management system (QMS) meet regulatory and quality compliance standards of a medical device company and to facilitate training on policies and procedures. The successful candidate must be an organized, self-motivated individual with the ability to adjust to workloads based upon the changing priorities that come with working in a fast-paced small company environment.

Position Description:

The Clinical Research Associate (CRA) is responsible for effectively managing investigational sites in compliance with study protocols, IRB requirements, applicable FDA regulations, and company procedures. With a reasonable level of guidance and under the direction of the Manager, Clinical Research, this position assists in the study execution from start-up to close-out at assigned study sites, including training site personnel, monitoring, reporting, and completion of site visit reports. 

Position Description:

As a member of the SetPoint Medical Operations team, the Manufacturing Engineer will be responsible for overseeing and improving the manufacturing processes of SetPoint’s novel medical device. The ideal candidate will have a robust understanding of medical device systems engineering and medical device manufacturing. As specific tasks arise, the right individual will need to gather relevant data, undertake independent research, formulate hypotheses, conduct experiments as needed, and draft reports for submission to quality and regulatory bodies. 

The Manufacturing Engineer will play a meaningful role in the development and implementation of continuous improvement efforts within the organization.

Position Description 

The Field Clinical Engineer (FCE) is responsible for proctoring implant procedures, providing ongoing training to surgeons and clinical sites on the use of the SetPoint system in accordance with the Instructions for Use and building effective relationships between paired rheumatologists and surgeons. The FCE in collaboration with the Sr. FCEs and the Clinical Research Associate (CRA) supports assigned clinical sites during study start-up activities, site initiation visits, and follow-up visits. The FCE will report to the Manager, Field Clinical Engineering.