Reports to: Head of Operations & Quality
Workplace type: Onsite
Overview:
Capstan Medical is a 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: The Manager of Manufacturing System Integration will lead the integration, testing, production and continuous improvement of robotic systems used in medical device applications. This individual will oversee cross-functional activities including New Product Introduction (NPI), process validation, end-of-line testing, system return analysis, and developing a system ready for commercialization. The role is both strategic and hands-on, ensuring that systems meet performance, quality, and regulatory standards as they move from engineering prototypes through full-scale production.
Description and Key Responsibilities:
Manufacturing & Integration Leadership
- Lead the integration and build of robotic medical systems on the production floor.
- Manage and optimize the end-to-end assembly process for complex electromechanical systems, ensuring repeatability and scalability.
- Own and improve the end-of-line test processes to validate system functionality and performance.
- Ensure proper documentation and traceability of integration steps, test outcomes, and deviations.
- Partner with Operations team to deliver Robot systems that meet business needs.
- Partner with Operations team on Industrial Engineering activities.
Team Management
- Manage and develop Manufacturing Engineers and Technicians.
- Provide foresight, training, mentorship, and technical direction to ensure team readiness for new products and processes.
- Collaborate cross-functionally with Quality, R&D, and Field Service (future) to ensure alignment from design through manufacturing and future post-market support.
New Product Introduction (NPI)
- Partner with R&D to transition new robotic platforms from prototype to manufacturing.
- Lead Design for Manufacturing (DFM), Design for Assembly (DFA), and Design for Test (DFT) activities.
- Coordinate, forecast and detail plan validation builds, strategy and production ramp-up readiness.
Process Validation & Quality
- Develop and execute IQ/OQ/PQ protocols for critical processes in alignment with FDA and ISO 13485 standards.
- Drive root cause analysis and corrective actions related to system integration defects or yield issues.
- Support audit readiness and documentation for quality systems and regulatory compliance.
Test Development & Automation
- Oversee the manufacturing side of this partnership with the Software group to ensure testing is implemented when needed and at the caliber needed.
- Collaborate with Software and Systems Engineering to define and maintain system-level test coverage and traceability.
- Maintain and calibrate test equipment (instruments), benches, and stations used in production to ensure reproducibility and reliability.
System Return & Re-Testing
- Manage intake, triage, and retesting of returned robotic systems from the field.
- Lead failure analysis activities and generate corrective actions for systemic issues.
- Coordinate rework or refurbishment activities as needed.
Continuous Improvement
- Identify and implement improvements to reduce cycle time, improve first-pass yield, and increase overall manufacturability.
- Lead efforts across the Manufacturing and R&D organizations to pull design updates into manufacturing for manufacturability.
- Use lean manufacturing tools (e.g., 5S, Kaizen, Value Stream Mapping) to streamline integration workflows.
Skills:
- Experience in Medical Device Manufacturing, QSR and 13485.
- Proficiency in Python, C, MATLAB or ROS for automation, test script creation and robot control
- Understanding of robotic systems and components such as motors, brakes, gear boxes
- Data forward: Ability to harness, analyze and visualize data in Python or similar
- Working knowledge of embedded system design to the degree of implementing tests around robotic hardware.
- Firm grasp of engineering fundamentals such as elasticity, torque, efficiency or ability to collect and synthesize inputs from experts.
- Strong communication, collaboration/teamwork and project management skills.
- Can do attitude.
Requirements:
- 7+ years experience
- Engineering degree in Mechanical, Computer Engineering, Electrical Engineering, Physics, Computer Science or related field.
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.