Entity: Occam-Labs
Reports to: Clinical Development Engineer
Workplace Type: Hybrid
About us:
Occam Labs is an engineering incubator targeting early-stage medical device design. We focus on cultivating cutting edge technology centered on patient value. Our team is highly collaborative and hands-on, takes pride in iterating quickly, and believes that the best ideas can come from anywhere or any person! We always have multiple programs in the pipeline, so as a small team, we tend to wear multiple hats on a daily basis.
Occam Labs is uniquely positioned in Santa Cruz, which we have chosen to be geographically close-to but intentionally separate from the greater SF Bay Area. This gives us access to the amazing technical talent of the bay area but in an environment that we feel is conducive to doing our best creative work. Our office is located in a repurposed warehouse space that used to be the Wrigley Gum factory, now the funky/diverse home to several bicycle companies, many art and architecture studios, a maker space, and several biotech startups. It is adjacent to large tracts of open space with bicycle trails straight from the office doors offering access to the hills and beaches of Wilder Ranch State Park for road/mountain bicycle riding, hiking, and surfing.
Currently, our active programs at Occam Labs target catheter-based, repair devices for diseases that affect the heart. These kinds of devices present patients with compelling, minimally invasive alternatives to traditional surgical methods. For most patients, this means less pain after surgery and being able to return to normal life much more quickly. For many older patients, reducing surgical trauma can make the difference between life and death. Our current strength is in micro-scale mechanical medical devices on the cutting edge of medicine, but we are constantly evolving. The team has a collective background designing a wide variety of medical devices including cardiac devices, catheter-based devices, collapsible implants, surgical tools and robotic systems.
Description:
- As a Senior Clinical Development & Imaging Specialist, you will work internally with cross-functional team 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 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 including physicians and 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
- Strong experience with clinical research studies, including site management
- Minimum 3+ years with CT and ultrasound imaging
- 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
Why join us:
- We offer a fun, fast-paced, collaborative environment where you will be working on transformational technologies in the cardiac healthcare space that can make a meaningful impact for patients.
- We offer outstanding benefits with medical, dental, and vision covered at 100% for you and your family, as well as flex time off.
- We thrive in our work-hard, play-hard environment. Bring your bike or running shoes if you’d like or just be ready to enjoy a fun office outing. We enjoy time inside the office and out!
We are an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, national origin, sex, sexual orientation, gender identity, veteran status, and disability, or other legally protected status.