Field Clinical Engineer

Job Title:

Field Clinical Engineer – Cardiopulmonary Intervention Company Overview

Our client is a venture-backed cardiopulmonary interventional device company developing a first-in-class catheter-based therapy for pulmonary hypertension and heart failure — disease states with significant unmet clinical need.

Founded in 2013 and supported by leading global investors, the company has raised over $100M to advance its Pulmonary Artery Denervation (PADN) technology. The system is approved and commercialized internationally and is now progressing through FDA IDE clinical trials in the United States, supported by CMS reimbursement for pivotal studies.

As the organization rapidly expands to 30–50 U.S. clinical trial sites, it is building a specialized field-based clinical team to support investigator‑led research, protocol execution, and high‑quality data generation.

The Field Clinical Engineer – Clinical Trials is a key member of the U.S. Clinical Affairs organization and will play a central role in IDE study execution, site enablement, and procedural consistency across a growing network of investigational sites.

This role partners closely with Principal Investigators, Study Coordinators, cath lab teams, and internal Clinical, Medical, and Regulatory stakeholders to ensure safe, compliant, and reproducible use of the investigational system while supporting the generation of high‑quality clinical data.

While procedural presence in the cath lab is required, the emphasis of this role is clinical trial support rather than case coverage.

• Serve as the primary field‑based clinical resource for U.S. IDE study sites.
• Support site activation, training, and readiness as new clinical sites come online.
• Partner with investigators and study coordinators to support:
• Patient screening and enrollment workflows
• Protocol adherence and procedural standardization
• Follow‑up and data completeness
• Ensure accurate and compliant collection of procedural and clinical data in alignment with IDE requirements.

• Provide on‑site support during investigational PADN procedures as a technical and clinical subject‑matter expert.
• Guide investigators through device setup, use, and procedural flow in accordance with the clinical protocol and IFU.
• Interpret and communicate relevant procedural information including:
• Angiographic imaging
• Hemodynamic measurements
• Physiologic and vital sign trends
• Maintain situational awareness in the cath lab, demonstrating strong understanding of sterile technique and procedural dynamics.

• Act as a key interface between the field and internal Clinical Affairs, Medical Affairs, and Regulatory teams.
• Provide structured feedback from sites to support:
• Protocol optimization
• Training improvements
• Device performance insights
• Assist with audit readiness, monitoring visits, and site compliance activities as needed.

• Experience supporting interventional cardiology, structural heart, electrophysiology, or vascular procedures in a clinical or research setting.
• Background may include:
• Field Clinical Engineer / Clinical Specialist (interventional devices)
• Cath Lab RN or Technologist with clinical research exposure
• Clinical Research Coordinator with device trial experience
• Biomedical Engineer or related technical discipline
• Demonstrated familiarity with:
• FDA IDE clinical trials
• Patient screening, enrollment, and follow‑up processes
• Cath lab workflows and procedural best practices
• Strong communication skills with the ability to build credibility with physicians, coordinators, and hospital staff.
• Highly organized and self‑directed; comfortable supporting multiple sites across the U.S.
• Willingness to travel approximately 50% nationally.

• Be part of early U.S. clinical team for a first‑in‑class therapy
• Direct exposure to pivotal IDE trials with CMS coverage
• High visibility with Clinical Affairs leadership and investigators
• Opportunity to grow into Senior Clinical Affairs, Clinical Program Lead, or Medical Affairs roles as the company scales