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Capstan Medical, Inc.

Posted 4 months ago

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Senior Manufacturing Engineer, Component Engineer

Santa Cruz, CaliforniaOn-siteFull-time

AI Summary

Senior Manufacturing Engineer responsible for scaling production and sustaining manufacturing of Capstan accessories and the Capstan Delivery System, performing hands-on process development, troubleshooting, and supplier collaboration in a regulated medtech environment.

About this role

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

    • Skills

    Electromechanical AssembliesFDA QSRISO 13485Manufacturing Process DevelopmentPFMEAProcess ValidationRoot-cause AnalysisSingle-use DevicesSPCSupplier Quality

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