Homeoffice Clinical Development Senior Specialist - Imaging presso 4C Medical Tech

ABOUT 4C MEDICAL TECHNOLOGIES:

We are a small but mighty, well-financed team dedicated to proving the effectiveness of our innovative, life-enhancing, lifesaving therapy. 4C Medical Technologies, Inc., located in Maple Grove, MN, is pioneering the next generation of transcatheter mitral valve replacement (TMVR) technology. Our Alta Valve is currently in the clinical trial phase of FDA approval.

POSITION SCOPE AND PURPOSE

Lead procedural imaging optimization and physician education for AltaValve TMVR procedures, with primary focus on echocardiographic guidance and assessment. Drive imaging protocol development and serve as technical expert for intraprocedural echo imaging across clinical sites.

RESPONSIBILITIES

• Develop and Refine Imaging Protocols: Create and update standardized imaging protocols for procedures, ensuring consistency and quality across all stages.
• Lead Procedural Training and Education: Train and provide hands-on education to clinical teams, including physicians and sonographers, on using echo imaging for device deployment.
• Provide Real-Time Imaging Support: Offer expert guidance and technical support during live procedures to ensure optimal device positioning and to troubleshoot any imaging challenges.
• Manage Imaging Quality Assurance: Conduct post-procedure reviews, analyze data trends, and ensure adherence to imaging protocols to maintain high standards.
• Serve as Imaging Subject Matter Expert (SME): Act as the key point of contact for imaging, providing expertise for device development, regulatory submissions, and clinical publications.
• Support Clinical Trial Imaging: Ensure imaging data quality and compliance with regulatory requirements for clinical trials.
• Assess and Support Clinical Sites: Evaluate site capabilities, recommend equipment or training, and support patient screening through comprehensive imaging reviews.
• Create Educational Resources: Develop and update imaging-focused training materials and competency assessments.
• Collaborate with R&D: Integrate clinical imaging feedback directly into new device development and procedural improvements.
• Troubleshoot and Innovate: Solve complex imaging issues and recommend innovative solutions to overcome procedural barriers.

 EDUCATION

• Associate’s degree in cardiovascular technology, diagnostic medical sonography, or related clinical field. Bachelor’s degree or certification in cardiac imaging preferred.

EXPERIENCE

• 5+ years of cardiac imaging experience, with at least 2 years in structural heart interventions
• Extensive experience with transesophageal echocardiography in interventional settings
• Demonstrated expertise in transcatheter mitral valve procedures or similar structural heart interventions
• Registered Diagnostic Cardiac Sonographer (RDCS) certification required
• Experience with multimodality cardiac imaging (CT, MRI, angiography) preferred
• Ability to travel extensively, both domestic and international

KNOWLEDGE, ABILITIES, SKILLS

• Echocardiography Expertise: You have a deep understanding of advanced echocardiographic principles, including 3D and fusion imaging, along with mastery of image optimization techniques.
• Structural Heart Knowledge: You're a subject matter expert in transcatheter mitral valve replacement (TMVR) and other structural heart procedures, including device-tissue interactions and identifying complications.
• Procedural Support: You're skilled in providing imaging-guided support during device positioning and deployment in high-pressure environments.
• Regulatory Compliance: You understand and apply FDA guidelines, Good Clinical Practice (GCP), and imaging core lab standards to ensure compliance.
• Technical Training and Education: You have a proven ability to educate and train clinical teams on complex imaging concepts, developing comprehensive educational materials and competency assessments.
• Data Analysis and Management: You're proficient with imaging analysis software and data management systems, capable of analyzing complex imaging data.
• Project and Site Management: You can effectively manage and coordinate imaging activities across multiple clinical sites.
• Problem-Solving: You excel at troubleshooting and providing solutions for complex imaging challenges.
• Communication Skills: You have strong interpersonal and presentation skills, enabling you to effectively communicate with both technical and clinical audiences.
• Professionalism: You demonstrate exceptional organizational skills, attention to detail, and the ability to maintain composure under pressure.