TRICARDIA · 1 day ago
Director, Field Clinical Engineering
Tricardia is partnering with an innovative medical device company developing a breakthrough therapy for Acute Decompensated Heart Failure (ADHF). The Field Clinical Engineering Director will lead the FCE team, contribute as a hands-on expert, and play a key role in clinical trial execution, site support, training, and product development.
Responsibilities
Lead the Field Clinical Engineering team, set objectives, and ensure alignment with clinical and organizational goals
Oversee and participate in clinical trials, ensuring compliance with protocols, SOPs, and regulatory requirements
Serve as a clinical subject matter expert in ADHF and cardiovascular device trials
Provide expert guidance during the procedure and provide hands-on support to patients during therapy
Collaborate with investigators, research staff, and cross-functional internal teams (R&D, Regulatory, Quality, Technical Operations)
Support trial planning, site training, enrollment, monitoring, and logistics
Provide clinical insights to guide product development and process improvements
Manage clinical supplies, study reporting, and investigational product accountability
Travel domestically and internationally as needed (~50%+)
Qualification
Required
Bachelor's degree in Engineering, Nursing, or a related medical field (RN, PT); advanced degrees a plus
10+ years in clinical research, including medical device trials; 2+ years in leadership or management
Experience supporting procedures for heart failure or cardiovascular device studies
Strong knowledge of GCP, ISO, and global regulatory requirements
Excellent communication and organizational skills, with the ability to manage multiple priorities
Hands-on, flexible, and willing to travel