Job Overview:
As a Senior Clinical Development & Imaging Specialist, you will work internally with cross-functional teams, as well as externally with clinical partners, to support preclinical activities for Capstan Medical and Versa Vascular mitral and tricuspid valve products. The role is fast-paced and ever-evolving, requiring excellent organizational and project management skills, with the ability to travel to sites domestically and internationally.
- Support preclinical activities including developing protocols, performing studies, and summarizing learnings
- Provide input on clinical protocol and strategies
- Provide expertise and clinical insights on procedural development
- Develop clinical education materials (IFUs, training materials)
- Perform measurements and analysis using CT, TEE/TTE, and clinical history to support screening activities
- Provide demos and training for a variety of audiences, i.e.. physicians, internal stakeholders
- Provide case support as part of a team, at multiple roles including device proctoring, imaging support, and device preparation
- Provide site management, including site activation, coordinating cases, and follow-up
Skills:
- Experience with preclinical labs and direct handling of cardiac tissue
- Experience with echocardiographic imaging of the mitral and/or tricuspid valve
- Experience using CT segmentation software
- Understanding of how early design decisions cascade into outcomes later. Ability to make smart decisions regarding clinical workflow, regulations, and risk management to save time and effort later
Requirements:
- Bachelor’s Degree required. Advanced degree in Biomedical, Science, Engineering is a plus.
- Minimum of 5 years of relevant clinical experience
- Minimum of 3+ years mitral or tricuspid device field experience
- 3+ years of CT and/or ultrasound imaging experience is strongly desired
- Strong experience with clinical research studies, including site management
- Adept with medical device development processes
- Ability to work onsite in Santa Cruz as needed
- Ability to travel up to 75% time with overnight stays, including international travel
- Ability to work outside the Monday-Friday, 9am-5pm schedule, especially to account for travel and different geographies
- West Coast preferred