Field Clinical Engineer (Midwest Region)
September 18th, 2017
HLT, Inc. is a clinical-trial stage company founded in Minnesota in 2002. We manufacture a transcatheter heart valve system, consisting of a catheter-based delivery system and heart valve, to treat aortic valve disease. The procedure is performed by an interventional cardiologist / cardiac surgeon in a cardiac catheterization laboratory, and is expected to be both less invasive and less costly than an open heart valve replacement procedure. The company currently employs approximately 100 people in Maple Grove, Minnesota.
In 2010 HLT was acquired by The Bracco Group, an international company active in the healthcare sector through Bracco Imaging. The group employs more than 3,300 employees worldwide and has annual total consolidated revenues of more than $1 billion.
HLT seeks passionate and talented people who can start contributing from day one. We want innovators seeking to advance the state of the art to improve patient outcomes.
This position in the Clinical Programs department will be based in the Midwest, preferably in Minnesota, and is responsible for day-to-day field implementation of HLT’s multi-center clinical investigations in accordance with corporate objectives, EU and FDA guidelines and protocols. The Field Clinical Engineer (FCE) is the primary site contact with respect to study recruitment, patient selection, and implant procedure support, requiring excellent clinical and technical skills. This position requires strong people skills, with the ability to develop relationships with influential thought leaders and centers of excellence worldwide, while delivering consistent results. To be successful, this individual also requires strong technical and clinical skills, and to be comfortable and experienced with providing direction to physicians in an interventional cath lab or hybrid suite setting.
Primary Duties and Responsibilities:
- Manage investigational site-based activities related to HLT’s ongoing clinical trials with respect to study recruitment, patient selection, and implant procedure support
- Work closely with supervisor (Director of Field Clinical Engineering) to assure integration of group objectives with departmental objectives
- Develop relationships with key site personnel required for a successful field clinical organization, such as communication, relationship building, and engagement, while performing site initiation and management activities
- Provide education and training of clinical personnel (physicians and nurses) on protocols, clinical processes, and the application of HLT’s catheter-based valve and its associated delivery system
- Provide appropriate technical support, including device preparation, patient selection and case proctoring, for clinical procedures in an interventional cath lab or hybrid suite setting. These procedures might include both implants and follow-up visits and troubleshooting of difficult cases will be required.
- The ability to provide this support independently is required and critical
- Provide oversight of junior HLT support personnel (Field Clinical Specialists) in the areas of device preparation, Case Report Form completion and inventory management
- Demonstrate technical leadership by working with the R&D, Marketing and Quality functions to provide input on investigator feedback, product ideas, performance, competitive position, developments and therapeutic trends
- Ensure the FCE group’s compliance to CE Mark & FDA regulations, study protocols and clinical department standard operating procedures by maintaining up to date knowledge
- Apply a full understanding of area specialization to resolve a wide range of issues in creative ways
- Assist in providing transitional education for clinical center personnel and sales representatives
- Partner with the Director of Field Clinical Engineering to establish metrics, as well as field visit observations, to assess progress with site activation, enrollment objectives and site management progress
Qualifications (Knowledge, Skills & Abilities):
Minimum Education and Experience:
- B.S. or graduate degree in the health/life sciences, or engineering
- Minimum of 3 years, preferably 5-7 years, in a Field Clinical Specialist or Engineer role
- Significant direct cardiovascular case proctoring experience in an interventional cath lab or hybrid suite setting is required. Specific experience in TAVR a distinct advantage
- Complete understanding of the wide application of technical principles, theories, therapies, and concepts in the cardiovascular field of valve disease. Familiarity with key imaging technologies (e.g. echocardiography, CT and MRI) is desirable.
- Thorough understanding of in-house/field study management and its dynamics/interactions
- Demonstrated ability to handle ambiguity/lack of job routine
- Travel requirement 50% initially but expected to be 60-70% during study enrollment phase, with some being on very short notice. Must be able to travel internationally
- Thorough understanding of applicable regulatory (CFR) and clinical science (GCP) guidelines both domestic (FDA) and international (ISO)
For further information about the position, please click here http://bit.ly/2fibMEz