Key Responsibilities and Required Skills for a Field Clinical Engineer

🎯 Role Definition

As a Field Clinical Engineer (FCE), you are the face of the company in the clinical environment, serving as the primary technical and clinical expert for our life-saving medical devices. You will work side-by-side with world-renowned physicians and medical teams in operating rooms, catheterization labs, and other clinical settings. This role requires a unique blend of deep technical knowledge, clinical acumen, and exceptional interpersonal skills. You will be responsible for ensuring the successful adoption and safe use of our technology by providing on-site case support, product training, and troubleshooting. Your insights from the field are invaluable, directly influencing next-generation product development and shaping the future of patient care.

📈 Career Progression

Typical Career Path

Entry Point From:

Biomedical Engineer (R&D or Quality)
Experienced Clinical Professional (e.g., RN, Cath Lab Tech, EP Tech, Surgical Tech)
Clinical Research Associate / Coordinator

Advancement To:

Senior / Principal Field Clinical Engineer
Field Clinical Manager / Regional Director
Product Manager or Clinical Marketing Manager

Lateral Moves:

Medical Device Sales Representative
Clinical Affairs or Clinical Science Liaison

Core Responsibilities

Primary Functions

Provide expert, on-site clinical and technical support during medical procedures, including device preparation, system operation, and real-time troubleshooting to ensure optimal patient outcomes and adherence to protocols.
Lead comprehensive training and education programs for physicians, fellows, nurses, and other hospital personnel on the correct use, advanced features, and clinical benefits of our medical device portfolio.
Serve as a primary resource for clinical trial execution at assigned sites, assisting with site qualification, initiation, patient screening, enrollment, and follow-up activities in strict compliance with Good Clinical Practice (GCP) and trial protocols.
Act as a critical liaison between the clinical field and internal teams, including R&D, Marketing, Sales, and Quality, by gathering and communicating user feedback, product performance data, and new clinical needs.
Master the full product portfolio, including the underlying science, clinical applications, and competitive landscape, to be a credible and trusted advisor to clinicians.
Independently manage and support a territory of clinical sites, including scheduling, travel logistics, and proactive communication to ensure consistent and reliable case coverage.
Assist in the launch of new products and technologies by executing field-based training, leading initial case support, and gathering early user feedback to ensure successful market adoption.
Troubleshoot complex technical and clinical issues with the device system promptly and effectively, often under high-pressure surgical or interventional environments.
Meticulously document case details, product performance, device tracking, and customer interactions in a CRM or other designated system for regulatory and business intelligence purposes.
Collaborate with the sales team to support business development activities, including clinical presentations, product demonstrations, and identifying opportunities for expansion within key accounts.
Ensure all activities are conducted in full compliance with company policies, industry regulations (e.g., FDA, AdvaMed), and hospital-specific credentialing and patient privacy (HIPAA) requirements.
Develop and maintain strong, collaborative relationships with key opinion leaders (KOLs), physicians, and clinical staff to foster advocacy and gather strategic insights.
Provide support for physician-sponsored research, registries, and publications by assisting with protocol development and data collection as needed.
Identify and report all observed or reported complaints, device malfunctions, and adverse events according to company Quality System and regulatory requirements.
Contribute to the creation and refinement of clinical training materials, technical manuals, quick-reference guides, and educational presentations for both internal and external audiences.
Represent the company with a high degree of professionalism at major medical conferences, trade shows, and workshops, assisting with booth activities and product demonstrations.
Support the continuous improvement of products by participating in design reviews and providing clinical-use risk analysis based on field experience.
Maintain and manage field inventory of devices, accessories, and capital equipment, ensuring all products are accounted for and in good working order.
Stay current with the latest clinical literature, treatment guidelines, and emerging technologies within the relevant medical specialty.
Mentor and train new Field Clinical Engineers and other team members, sharing best practices and fostering a culture of excellence.

Secondary Functions

Assist the sales team by providing in-depth clinical and technical expertise during presentations to potential and existing customers.
Contribute to the development and refinement of training curricula, technical manuals, and educational resources for internal and external audiences.
Attend and provide support at key medical conferences, workshops, and trade shows to represent the company and demonstrate product capabilities.
Manage and maintain consignment inventory, demo equipment, and other company assets in the field according to established policies.

Required Skills & Competencies

Hard Skills (Technical)

Deep understanding of human anatomy, physiology, and specific disease states (e.g., cardiovascular, structural heart, neurological, orthopedic).
Proficiency operating within sterile environments such as operating rooms (OR), catheterization labs (Cath Lab), or interventional radiology (IR) suites.
Strong knowledge of medical device regulations including FDA 21 CFR 820, ISO 13485, and Good Clinical Practice (GCP).
Ability to interpret complex clinical data, such as EKGs/EGMs, and diagnostic imaging like fluoroscopy, ultrasound, or CT scans.
Experience with clinical trial protocols, data collection methodologies, and electronic data capture (EDC) systems.
Technical aptitude for troubleshooting complex electromechanical, software-based, or implantable medical systems.
Familiarity with hospital information systems and standard office software (e.g., Salesforce, MS Office Suite).

Soft Skills

Exceptional interpersonal and communication skills, with a proven ability to build rapport and establish credibility with physicians, nurses, and hospital administrators.
Superior problem-solving and critical-thinking abilities, especially when making decisions under pressure in a high-stakes clinical environment.
Proven ability to teach or train complex technical and clinical concepts to a diverse audience with varying levels of experience.
High degree of autonomy, self-motivation, and outstanding organizational skills to manage a demanding travel schedule (often 50-75%) and multiple competing priorities.
Unwavering professional demeanor, emotional intelligence, patience, and composure in all situations.
A strong collaborative mindset to work effectively with cross-functional internal teams including Sales, R&D, Marketing, and Quality Assurance.

Education & Experience

Educational Background

Minimum Education:

Bachelor's Degree in a technical or clinical science field.

Preferred Education:

Master's Degree or other advanced degree (e.g., PhD, RN, BSN, PA).

Relevant Fields of Study:

Biomedical Engineering
Electrical or Mechanical Engineering
Nursing
Life Sciences (Biology, Physiology)

Experience Requirements

Typical Experience Range:

3-7 years of relevant experience in the medical device industry, a clinical setting, or a related technical field.

Preferred:

Direct experience as a Field Clinical Engineer, Clinical Specialist, or a similar field-based role in the medical device industry.
Hands-on clinical experience in a relevant setting such as a Cath Lab, EP Lab, Operating Room, or ICU, working directly with pertinent device technologies.