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.
Responsibilities & Skills:
Key Responsibilities:
· Support manufacturing development of new implant sizes, from engineering builds through design transfer and production release
· Adapt existing implant processes, work instructions, and tooling to new sizes, flagging size-dependent issues to the team
· Provide DFM/DFA feedback to R&D during design reviews and development builds
· Design, build, and qualify size-specific fixtures and tooling for assembly, loading, and inspection
· Plan and execute engineering, verification, and clinical builds with R&D, Quality, and Operations
· Draft and execute process characterization and validation protocols (IQ/OQ/PQ, TMV), using DOE and statistical tools to analyze results
· Draft and revise MPIs, DHRs, PFMEAs, inspection procedures, and engineering change orders for new product introductions
· Support supplier onboarding for new-size components, including first article inspections
· Train technicians/operators on new processes and support builds on the floor
· Investigate process and component NCRs and support root cause and corrective actions
Skills:
· Process Development - Ability to develop, document, and refine manufacturing processes for medical devices
· Validation - Experience writing and executing IQ/OQ/PQ protocols
· CAD & Fixture Design - Proficient in SolidWorks or similar for fixture/tooling design
· Root Cause Analysis - Experience with 5 Whys, Fishbone Diagrams, and other RCA methods
· Assembly Techniques - Familiarity with precision assembly, especially under a microscope, and biocompatible material handling
· Document Control - Ability to work within a QMS and manage DCNs
· Excellent communication, documentation, and problem-solving skills, with the ability to manage multiple priorities
Requirements:
Requirements:
· Bachelor's degree in Mechanical Engineering, Manufacturing Engineering, Biomedical Engineering, or related field
· Minimum 2 years of relevant experience in a medical device or regulated manufacturing environment, with exposure to new product development or design transfer
· Working knowledge of GMP, 21 CFR 820, and ISO 13485
· Experience with validation (IQ/OQ/PQ), risk management (FMEA), and statistical tools (Minitab, JMP)
· Preferred: experience with Class III implants or heart valves, cleanroom micro-assembly, or biological material handling
Skills Required
- Bachelor's degree in Mechanical Engineering, Manufacturing Engineering, Biomedical Engineering, or a related field
- At least 2 years of relevant experience in a medical device or regulated manufacturing environment
- Experience with new product development or design transfer
- Working knowledge of GMP, 21 CFR 820, and ISO 13485
- Experience with IQ/OQ/PQ validation
- Experience with risk management and FMEA
- Experience using statistical tools such as Minitab or JMP
- Experience developing, documenting, and refining medical device manufacturing processes
- Proficiency with SolidWorks or similar CAD software for fixture and tooling design
- Experience with root-cause analysis methods including 5 Whys and Fishbone Diagrams
- Familiarity with precision assembly, microscope-based assembly, and biocompatible material handling
- Ability to work within a QMS and manage document changes
- Experience with Class III implants or heart valves
- Experience with cleanroom micro-assembly or biological material handling
What We Do
Capstan Medical is a developer of robotic-enabled, minimally invasive solutions for treating structural heart disease. By merging surgical robotics with catheter-based technology and next-generation implants, the company aims to provide a patient-optimized approach to repair and replace heart valves, offering a significantly less invasive alternative to traditional open-heart surgery to improve patient outcomes and reduce recovery times.
