Job Description

Join UroMems and be part of the revolution in urological medical technologies!

UroMems is a pioneering company in the design, development, and commercialization of active implantable medical devices, transforming the management of urological disorders.

Why join us?

Innovation at the heart of our DNA: At UroMems, we work on disruptive clinical solutions addressing major medical needs, with a direct impact on improving patients' quality of life.

Born in the heart of the French Alps in Grenoble, we operate in one of the most dynamic environments for medical technologies, benefiting from a world-class research and innovation ecosystem.

A significant impact: Our devices address highly prevalent pathologies and crucial patient issues, giving profound meaning to every mission we undertake.

Now we are expanding our US presence by recruiting a Field Clinical Engineer to ensure day-to-day field clinical support activities in the next-stage clinical evaluation of its novel products.

The Field Clinical Engineer (FCE) will act as a liaison between UroMems and participating investigational sites to ensure successful execution of clinical trials. The FCE will provide clinical support during study implant procedures and follow-up visits, in compliance with regulatory and clinical trial requirements. The FCE will collaborate closely with cross-functional teams internally and with external stakeholders.

Key Responsibilities

• Provide technical support during surgical procedures and follow-up visits to ensure successful execution of clinical trials, in compliance with study protocol
• Subject Matter technical expert and participate in device programming and troubleshooting, as needed
• Train study physicians and investigational site staff on investigational products (features, workflow, etc.)
• Create and maintain solid relationships with academic and research institutions, clinical site staff and KOLs.
• Responsible for device accountability and tracking to ensure adequate investigational product is available at participating sites by collaborating with internal cross functional teams
• Involved in the compilation and follow up related to device inadequacies or deficiencies as they occur in clinical studies
• Provide technical support to study participants, under the guidance of study site personnel and assist in after-hours call support and activities
• Act as liaison between external stakeholders and internal cross functional team (e.g. R&D) to share relevant technical learnings for next generation product development.
• Create training materials related to study execution including device workflows, device training as needed
• Comply with the quality management system and all regulatory requirements applicable to implantable medical devices and clinical studies
• Maintain current knowledge and comply with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Good Clinical Practices (GCP), Company policies and standardized operating procedures (SOP).

Qualifications :

Education:

• Bachelor’s degree in biomedical, mechanical or electrical engineering

Experience:

• min 5+ years of proven experience in clinical field activities or on-site technical support using complex medical devices (preferably active implantable devices)
• Prior relevant experience in operating room environments, ideally complemented by experience with configurable devices & patient interactions
• Prior experience in multi-center clinical trials preferred

Skills:

• Excellent communication and interpersonal skills with physicians, site staff and hospital administration
• Strong problem-solving skills in stressful environments, with attention to detail
• Flexibility in responding to changing priorities or dealing with unexpected events
• Ability to travel 75% within and/or outside assigned region, including unpredictable travels on short notice
• Ability to lead clinical training on medical devices and clinical procedures
• Ability to fulfill and maintain background, health and credentialing requirements necessary to access customer facilities and the OR
• Understanding of GCP, HIPAA and regulatory compliance including guidelines for clinical trials

Other

Legal authorization to work in the U.S.

Job Tags

Similar Jobs