Field Clinical Engineer
March 19th, 2019
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. Experience can be substituted for a B.S. degree.
- 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.
- 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).
Please click the following link to apply for the position: https://bit.ly/2Hx3vfD