Direct Flow Medical has two locations, one in Santa Rosa and the second in Lake Forest, California. We are seeking highly motivated individuals who are looking for challenging employment opportunities to develop cutting edge medical devices. Please send your resume to hr@directflowmedical.com.
Research and Development – Tissue/Valve Engineer - Leads Company efforts in product and process development activities related to the design, testing, and production of the Companys implantable percutaneous aortic valve. Requirements include a Bachelors Degree in a Mechanical, Biomedical or Chemical field preferably in engineering, as well as 5-7 years of progressive experience in all phases of product development of implantable medical devices and tissue heart valve experience.
(Locations Santa Rosa or Lake Forest, CA)
Regulatory Specialist – Responsible for the development and coordination of regulatory documentation for U.S. and international submissions. Requirements include knowledge of medical terminology, FDA and international regulations, as well as strong writing skills. Requirements: Bachelors degree in a life science or scientific related field; or 4-6 years experience in regulatory affairs.
(Location: Santa Rosa, CA)
Clinical Engineer (US/EU Contractor) – This European based individual will be responsible for the coordination and on site use of the DFM device by the physicians. The clinical engineer will have thorough understanding of transcatheter aortic valve replacement and attends all clinical cases and animal studies, performs final device preparation and assembly activities, and documentation. A Bachelors degree in Mechanical or Biomedical Engineering and 3-5 years experience working in a cath. lab in or near the sterile field is required. Also requires strong knowledge of GCP and regulatory compliance guidelines and regulations for clinical trials as well as knowledge of clinical research study design.
Clinical Research Specialist – The Clinical Research Specialist (CRS) will assist with development and management of international and US clinical trials in compliance with applicable regulatory standards and company SOPs. The CRS will assist in overall conduct of the clinical trials including site selection, site activation, enrollment, follow up and study close out, assist with the development of investigational plans, informed consent, Case Report Forms (CRFS) and other clinical study documentation and regulatory submissions and assist in review, assessment, tracking and reporting of Serious Adverse Events (SAEs). Bachelor’s degree, or foreign equivalent, in engineering, life sciences, or related medical/scientific field, and two years of experience as a Clinical Research Specialist or Clinical Research Associate. Available to travel up to 20%.
Direct Flow Medical offers a competitive salary, full benefits and stock options. Direct Flow Medical, Inc. is an Equal Opportunity Employer. Our company does not unlawfully discriminate on the basis of race, color, religion, sex, national origin, age, disability, veteran status or marital status.