Principal Field Clinical Engineer

New Yesterday

About the role: The Principal Field Clinical Engineer (FCE) supports a growing department that manages a large pivotal study program based on an innovative medical device technology platform. The Senior FCE will be responsible for all aspects of case support and product education aimed at treating product education involving coronary interventions, including calcium modification. This role will be reporting to the Director, Field Clinical Operations. Responsibilities will include: Working in a general direction provides engineering, educational and technical support in response to field inquiries from physicians and health care professionals involving intravascular lithotripsy among other coronary products in the future. Performs work that involves a high degree of independence. Identifies and routinely uses the most effective, cost-efficient, and best business practices to execute processes; continually evaluates their effectiveness and appropriateness. Exercises independent judgment in planning, organizing and performing work, monitors performance and reports status to manager. Acts as a clinical interface between the medical community and the business. Demonstrates ability to build and sustain credible business relationships with customers and shares product expertise accordingly. Provides engineering, education and clinical support in response to field inquiries on an as-needed basis. Develops, leads and/or facilitates training and other programs for healthcare professionals. Provides insight, guidance, and feedback to management on market feedback and components of the next generation of products. Provides case coverage for multiple clinical trial sites in a region. Provides additional back-up support in the following areas -Clinical study monitoring/data collection; trouble shooting and new product in-service training to physicians and healthcare professionals Continuously developing technical skills relative to the overall company strategy, including learning opportunities. Assists with advanced educational seminars, and the preparation of educational materials. Assists with advanced product demonstrations to visiting physicians and healthcare professionals. Remains current on developments in field(s) of expertise, regulatory requirements, and working knowledge of company and competitor products, markets, objectives and industry trends. Resolves and/or facilitates resolution of problems including identifying causes to prevent reoccurrence. Performs related functions and responsibilities, on occasion, as assigned. Required qualifications: Minimum Bachelor’s degree in Engineering, Anatomy, Physiology related field or equivalent healthcare experience required. Minimum 5 years of experience in clinical research experience including coordinating multi-center trials with established technical expertise and knowledge Ability to travel up to 75-90% domestically and internationally. Visits include clinical sites and centers. Experience in presenting, writing and teaching clinical and medical information Experience with group presentations and hands-on experience with surgical catheter-based interventions Must be able to work effectively with internal groups such as R&D, Quality, Regulatory, technical specialists, and external stakeholders achieve assigned goals Ensure compliance with clinical study protocol, and identifying areas of concern and escalating when appropriate
Preferred qualifications: Excellent written and verbal communication skills, very strong interpersonal skills including proficiency in medical terminology Clinical Research experience in Medical Device Experience coordinating multi-center Cardiology trials Knowledge of Good Clinical Practices and trials, including feasibility IDE and post-market studies.
Location:
Los Angeles