Reports to: Director of Program Management
Workplace Type: Onsite
Capstan Medical: Creating a new standard for minimally invasive structural heart treatment.
About Us
Capstan Medical 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.
Capstan Medical 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 Capstan Medical 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.
Role Overview:
As Project Manager for our flagship robotic transcatheter valve replacement program, you will own end-to-end execution of one of the most complex and capital-intensive programs in structural heart. You will drive alignment within the Robot team (mechanical, electrical & software) through design freeze, V&V, clinical trials, and regulatory submission.
Key Responsibilities:
- Develop, maintain and actively manage detailed project schedules (MS Project) with dependencies, resources and critical path on a weekly basis
- Facilitate daily stand-ups, core team meetings, and technical working meetings
- Ensure full design control compliance: traceability matrices, design reviews, DHF completeness, and on time deliverables for critical phase gates
- Drive mitigation plans and escalate when needed
- Prepare clear updates, dashboards and decision materials for cross-functional program and leadership reviews
- Support vendor selection, and ongoing supplier management for key components and capital equipment
- Mentor junior project leads (engineering) and help instill project management discipline across the organization
- Work on site to keep a pulse in a fast moving environment
Required Qualifications:
- 5+ years of project management experience in medical devices; Class III implantable and/or robotic/capital
- Proven track record of shipping at least one cardiovascular implantable or robotic/capital system through FDA submission or approval
- Familiar with design controls (21 CFR 820.30, ISO 13485), risk management (ISO14971) and DHF maintenance
- Exceptional organization skills and attention to detail
- Strong influencing skills with no direct authority
- Bachelor’s degree in engineering or life sciences
Preferred Qualifications:
- Direct experience with structural heart valves (TAVR or TMVR) or robotic catheter delivery systems
- Core team lead or experience leading cross-functional projects
- Experience with early stage clinical trial studies (First In Human, Early Feasibility, etc)
- Prior Series B/C startup experience with successful exits or acquisitions
You Will Thrive If:
- You’re obsessed with schedules, risk management and keeping teams marching in lockstep
- You stay calm when timelines slip and can make recommendations on how to recover them
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.