Senior Manufacturing Engineer, Component Engineer
Capstan Medical, Inc.
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.
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
- 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
- Work directly with suppliers to resolve quality, yield, and performance issues
- Collaborate closely with R&D, Quality, Operations, and Supply Chain
- 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
$150k - $200k
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