Director, Structural Heart Supply Chain

Capstan Medical, Inc. • Santa Cruz, CA

12d • Onsite

About The Position

Capstan medical is Series C funded company aiming to commercial a robotic platform for delivering structural heart implants. 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.

Summary: We are seeking an execution-focused director to lead and scale our end-to-end supply chain operations. This leader will oversee the functions of procurement, planning, distribution/logistics, component engineering, and supplier quality, ensuring integration across internal manufacturing operations and external suppliers.
This is a leadership role, responsible for developing robust systems and processes that ensure supply continuity through high growth evolution, enable new product introductions, and ensure the highest standards of quality and compliance in a regulated medical device environment.

Requirements

• Bachelor’s degree in Supply chain management, Engineering, business, or related technical field.
• 10+ years of progressive experience in supply chain roles, including at least 5 years in leadership within a medical device, robotics, or complex electromechanical manufacturing environment.
• Deep understanding of FDA regulations, ISO 13485, and medical device quality systems.
• Proven experience building and scaling supply chain functions in high-growth, vertically integrated manufacturing environments.
• Familiarity with ERP, PLM, eQMS, MES, tableau and other digital tools.

Nice To Haves

• Master’s degree (MBA, MS in Engineering, or related field). Preference given to supply chain specific masters.

Responsibilities

• Develop and execute the company’s supply chain strategy in alignment with business goals, manufacturing plans, and regulatory requirements.
• Partner closely with R&D, Manufacturing, and Quality teams to support new product development, introduction and scale-up activities.
• Build and lead a high-performing, cross-functional supply chain team across procurement, planning, component engineering, logistics, and supplier quality.
• Lead sourcing strategies for direct and indirect materials with a focus on quality, delivery and cost.
• Establish and manage strategic supplier relationships, including contract negotiation, performance management, and risk mitigation.
• Establish business contingency plans to ensure supply continuity during steady state, high growth and black swan events.
• Drive supplier development initiatives to ensure alignment with our technical quality and regulatory and ISO standards.
• Oversee yearly, quarterly and monthly demand and supply planning processes to optimize inventory levels, ensure material availability, and support production schedules.
• Lead ERP implementation to ensure current and future (commercial) supply chain considerations are met while balancing current speed of development.
• Lead the component engineering function to ensure all materials, components, and subassemblies meet design specifications, manufacturability, and reliability requirements.
• Establish capability across supplier base and create improvement or mitigation plans where necessary.
• Collaborate with Design and R&D teams during new product development by developing a recommended supply base for specific processes to enable a seamless transfer to production.
• Oversee supplier quality systems and ensure compliance with FDA, ISO 13485, and other applicable regulatory requirements.
• Lead supplier audits, corrective actions, and continuous improvement initiatives.
• Direct the strategy and execution of domestic and international logistics, warehousing, and distribution operations.
• Ensure on-time delivery of components and finished goods while optimizing cost and efficiency, aiming for no less than a 100% system to case availability target.

Benefits

• We offer a fun, hands-on, fast-paced, collaborative environment where you will be working on transformational technologies in the cardiac healthcare space.
• We offer projects and training to continue your learning and technical growth.
• 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!

What This Job Offers

• Job Type: Full-time
• Career Level: Director