Field Clinical Engineer

Job DescriptionJob Description

We are a fast-growing medical device company developing advanced Software as a Medical Device (SaMD) solutions for interventional cardiology and structural heart procedures. Our flagship technology integrates real-time fluoroscopy with pre-procedure 3D CT annotations to provide precise intra-procedural guidance, enhancing safety and clinical outcomes.

Our innovation combines CT preprocessing, fluoroscopy preprocessing, AI-driven detection and tracking, anatomical landmark detection, and personalized DRR-based network training with cutting-edge registration protocols. We operate with a small, highly skilled in-house engineering team, supplemented by specialized contractors across several continents.

Cara Medical (https://www.cara-medical.co/) is a rapidly growing Medical Device startup that develops an innovative solution to noninvasively image the cardiac conduction system. Our technology personalizes and optimizes pacing and structural heart procedures. Cara recently received Breakthrough Device designation from the FDA, and we are planning on submitting for FDA approval during 2025. We are currently running clinical studies in sites in Europe, the US and Asia.

Cara is looking to hire a Field Clinical Engineer (FCE) located in the US (preferably on the East Coast) and who will report to the Clinical Studies Manager. The FCE will be responsible for supporting clinical sites and will be the primary point of contact for the sites' clinical team. Once we obtain FDA approval and launch the product, the FCE will transition to onsite customer support.

Main Responsibilities

• Supporting clinical trials for the Cara System: site installation, case support, EDC etc.
• Manage and provide accountability for day-to-day operations of the study, as defined by the contract and according to ICH/GCP and all other applicable laws, rules, and regulations.
• Edit check specifications, data analysis plan, and final study report, when applicable.
• Serve as primary Sponsor contact for operational project-specific issues and study deliverables.
• Maintain in-depth knowledge of protocol, therapeutic area, and indication.
• Establish strong relationships with site investigators and other KOLs.
• Conduct periodic site visits (engagement and management).
• Administrative clinical department support.

Qualifications

• Bachelor's degree in a health-related field; advanced degree in a health-related field
• 3+ years of experience in the medical device arena
• 3+ years of Clinical Affairs / field clinical specialist
• Familiar with catheter lab / operation room environment
• Excellent written and oral English communication skills
• Good organizational and technical skills
• CT reading / ECG analysis skills
• Willing to travel often

Personal skills

• Excellent communication, presentation, interpersonal and problem-solving skills
• Ability to work independently as well as collaboratively in a start-up environment
• Work under time and pressure constrains
• Positive attitude

We are currently expanding our team. As a start-up, we are fast paced and have a shared goal to succeed in developing unmet healthcare needs in the most efficient way. If you share this vision and are interested in joining us - please apply. We look forward to hearing from you.