Sr. Field Clinical Engineer

Position Summary

The Senior Field Clinical Engineer (Senior FCE) serves as the senior technical and clinical liaison between physicians and the company, focusing on clinical research, product development, field technical services, and training.

Essential Functions

• Conduct and coordinate field research activities, including patient fitting, interviewing, and data collection.

• Facilitate and assist with investigator-initiated and company-sponsored protocol generation.

• Recruit and nominate study investigators, research centers, and clinical sites in coordination with clinical operations.

• Organize and provide support for study sites, including patient procedures, scheduling, and follow-up documentation.

• Coordinate data collection and resolve study- and technology-related issues at clinical research centers.

• Serve as a liaison between Product Development and physicians for clinical device feedback and improvement recommendations.

• Coordinate and conduct clinical device testing, beta testing, and in-house testing of new products.

• Develop and refine clinical protocols in collaboration with internal teams and physicians.

• Aid in the submission of research findings for scientific presentations and congresses.

• Collaborate with the company and physicians to support the development of PowerPoint presentations.

• Assist with abstract and manuscript preparation, including literature review and data synthesis as needed.

• Conduct literature searches and contribute to generation of technical memos and marketing literature reviews.

• Conduct individualized clinical research education and training with physicians and clinical staff.

• Assist with field training and onboarding of sales team members on programming methods and clinical protocols.

• Support physicians with technology utilization, engineering guidance, and clinical application.

• Follow up on and resolve reported technical issues in the field in a timely manner.

• Troubleshoot complex field technical problems and respond to issues that may affect patient safety.

• Document technical problems thoroughly and escalate appropriately per company procedures.

• Communicate technical findings and explanations clearly to clinic personnel and internal stakeholders.

• Aid in marketing support, including identifying key opinion leaders and influential clinicians in the field, and reviewing and providing clinical feedback on marketing materials.

• Assist the sales team in identifying and targeting physicians for clinical programs.

• Facilitate device programming support in the field as needed.

• Coordinate data collection efforts in support of sales and clinical objectives.

• Mentor and develop junior Field Clinical Engineers.

• Model exemplary standards of clinical conduct, documentation quality, and cross-functional collaboration.

• Adhere to the letter and spirit of the company Code of Conduct, the AdvaMed Code, MedTech Code, and all other company policies.

• Ensure compliance with applicable governmental laws, rules, and regulations, both in the United States and internationally, by completing introductory and annual training and maintaining knowledge of compliance as it applies to the position.

• Represent the company in a professional manner and uphold the highest standards of ethical business practices and socially responsible conduct in all interactions with other employees, customers, suppliers, and other third parties.

Qualifications

• Bachelor’s degree in Engineering, Life Sciences, or a related technical field with a minimum of 6 years of field experience supporting implantable medical devices.
• Prior experience in a Field Clinical Engineer or equivalent clinical/technical role within the medical device industry strongly preferred.
• Master’s degree (MS) or Doctorate (PhD) in Electrical Engineering, Biomedical Engineering, Computer Science, or a related discipline with 8 or more years of field experience.
• Strong working knowledge of human physiology, neuroanatomy, physician and hospital practices, and operating room etiquette.
• Experience with IDE clinical trial conduct, GCP principles, and applicable regulatory requirements.
• Excellent verbal and written communication skills.
• Attention to detail and self-starter with the ability to independently organize travel and manage daily work schedules.
• Advanced critical thinking and problem-solving skills.
• Proficiency in using Microsoft Office products.
• Ability to travel up to 50–70% of the time, including overnight and weekend travel as required by field responsibilities.

Physical Demands

• Required to sit; climb or balance; and stoop, kneel, crouch or crawl.
• Required to regularly lift and/or move up to 10 pounds, and occasionally lift and/or move up to 25 pounds.
• Required to possess specific vision abilities, including: close vision, distance vision, color vision, peripheral vision, depth perception and capacity to adjust focus.