Field Clinical Engineer (midwest or East Coast)

Location: MN
Job Type: Direct Hire
Salary: $95,000.00 - $125,000.00
Date: 11/6/2017
Job ID: 02531752
Job Description
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 companies 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 companies 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 companies 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 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):
  • 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 must.
  • 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).