Senior Manufacturing Engineer, Component Engineer

At Capstan Medical, we’re building one of the most exciting and innovative companies in medtech-developing a first-of-its-kind robotic platform for minimally invasive heart valve treatment. Our team combines surgical robotics, catheter-based delivery, and next-generation implants to transform complex procedures into safer, lower-stress solutions for patients and clinicians alike. As a highly collaborative, hands-on team, we move fast, wear multiple hats, and believe the best ideas can come from anyone.

Based in Santa Cruz, our unique workspace blends cutting-edge Bay Area innovation with a lifestyle-driven environment near trails, beaches, and open space-creating the perfect place to do meaningful, career-defining work.

About the Role

We are seeking a Senior Manufacturing Engineer to play a critical role in scaling and sustaining production of Capstan accessories, including the Capital Controller and single-use devices. This role will also involve component engineering for the current generation Capstan Delivery System supporting component and supplier related issues.

This is a hands-on, startup-style role for an engineer who is comfortable operating in ambiguity, moving quickly, and owning problems end-to-end while maintaining rigor expected in a regulated medical device environment.

Manufacturing Support & Process Development

• Own manufacturing process development and day-to-day production support for Capstan accessories, including Capital Controller and single-use devices.
• Develop, characterize, and improve manufacturing processes to support rapid iteration and scalable production
• Create and maintain manufacturing documentation including work instructions, process flows, and build documentation
• Troubleshoot complex manufacturing and assembly issues on the floor with a strong bias to action

Component Engineering & Nonconformance Ownership

• Serve as the engineering owner for all component-level issues on current-generation Delivery System.
• Lead investigations and root cause analysis for component- and supplier-related nonconformances (NCRs)
• Drive containment, disposition, and corrective actions in partnership with Quality, Supply Chain, and suppliers

Supplier Partnership & Cross-Functional Execution

• Work directly with suppliers to resolve quality, yield, and performance issues
• Collaborate closely with R&D, Quality, Operations, and Supply Chain

Required Qualifications

• Bachelor’s degree in Mechanical, Manufacturing, Industrial, or related Engineering discipline
• 5+ years of experience in manufacturing engineering, preferably in medical devices or regulated industries
• Strong background in component engineering and supplier quality issue resolution
• Hands-on production support experience
• Experience with electromechanical assemblies and single-use devices
• Familiarity with ISO 13485 and FDA QSR
• Experience with process validation, PFMEA, SPC