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 is responsible for day-to-day field implementation of HLT’s multi-center clinical investigations in accordance with corporate objectives, and EU and FDA guidelines. The Field Clinical Engineer (FCE) is the primary site contact with respect to study recruitment, patient selection, and implant procedure support. 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 OR suite setting.
Primary Duties and Responsibilities:
- Manage investigational site-based activities related to HLT’s ongoing clinical trials with respect to implant procedure support.
- Work closely with supervisor to assure integration of group objectives with departmental objectives.
- Develop relationships with site personnel (physician and support staff) 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 support staff) on the Instructions for Use (IFU) 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 OR suite setting. Apply a full understanding of area specialization to resolve a wide range of issues in creative ways. The ability to provide this support independently is required and critical.
- Ensure compliance to the clinical department Standard Operating Procedures (SOPs) and Work Instructions (WIs) by maintaining up to date knowledge.
- Provide oversight of junior HLT support personnel (Field Clinical Specialists)
- 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.
- Assist in providing education for HLT personnel (i.e. Sales Representatives) for commercialization or hospital personnel, as applicable.
- Partner with Supervisor 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):
- Bachelor of Science (B.S.) in the health/life sciences, engineering, or other applicable field.
- Minimum of five (5) years of direct cardiovascular experience in an interventional cath lab, Operating Room, or hybrid OR suite setting.
- Minimum of two (2) years of direct cardiovascular case proctoring experience in an interventional cath lab, Operating Room, or hybrid OR suite setting for a medical device company.
- Complete understanding of the wide application of technical principles, theories, therapies, and concepts in the cardiovascular field of valve disease.
- Thorough understanding of in-house/field study management and its dynamics/interactions.
- Demonstrated ability to handle ambiguity/lack of job routine.
- Initial travel requirement ~50%, with some being on very short notice. Must be able to travel internationally.
Experience can be substituted for a B.S. degree.
- TAVR experience in hospital, clinic, research, or sales preferred.
- Significant hospital experience can be substituted for medical device experience.
- Familiarity with key imaging technologies (e.g. echocardiography, CT and MRI) is desirable.
- Working knowledge of applicable regulatory (CFR) and clinical science (GCP) guidelines both domestic (FDA) and international (ISO).