Capstan Medical

Catheter-based heart valve replacement via robotics

Senior/Staff Manufacturing Engineer - Robot Productization

Manufacturing EngineeringConfirmed live in the last 24 hours

Full-timeSanta Cruz, CA, USANo salary listed

About the Job

Requirements

A bachelor's or master's degree in Mechanical Engineering, Manufacturing Engineering, Mechatronics, Electrical Engineering, or a related field.
At least 7 years of manufacturing engineering experience for Senior level, or 10 or more years for Staff level; a master's degree may offset years of experience.
A proven track record bringing complex electro-mechanical systems from development into production, such as robotics or medical capital equipment.
Hands-on experience developing special processes such as bonding, welding, press fits, and crimping.
Experience designing and qualifying fixtures and tooling using computer-aided design software such as SolidWorks.
Working knowledge of process controls and statistics, including design of experiments, process capability, and Gage R&R, and process risk tools such as PFMEA.
Demonstrated success leading root cause investigations and implementing design and process fixes.
Experience working in a regulated environment, such as ISO 13485 or 21 CFR 820.
Strong project leadership, with the ability to plan, drive, and close cross-functional work without formal authority.
Ability to work hands-on, independently, and with attention to detail in a fast-paced environment.

Responsibilities

Lead productization of new robotic subsystems, partnering with R&D from early engineering builds through pre-DV, DV, and clinical builds.
Own the path from design to product by driving open issues, decisions, and actions to closure across R&D, Quality, Supply Chain, and Manufacturing, and escalate risks early to keep builds on schedule.
Plan and drive readiness for each development build, including documentation, fixtures, materials, equipment, line setup, and training; use each build to identify and close gaps before the next.
Develop and characterize special processes, including adhesive bonding and curing, welding, press fits, and crimping, using surrogate testing and design of experiments.
Create and mature manufacturing documentation, including MPIs, DHRs, and in-process inspection points, from redline drafts to released procedures.
Design, qualify, and release assembly fixtures, tooling, and equipment, and define calibration and preventive maintenance needs.
Provide early design-for-manufacturing and design-for-assembly feedback, including error-proofing features, to make designs easier to build, test, and service.
Define line layout, process flow, cycle time, and staffing needs for new products, including facility, utility, safety, and environmental requirements.
Make make-versus-buy decisions for processes and partner with suppliers on outsourced processes and critical components.
Establish traceability and serialization for assemblies, components, and firmware/software versions.
Own process risk management using PFMEA and drive process capability and process validation plans with Quality.
Partner with manufacturing software engineers to integrate test, calibration, and firmware loading into the build flow.
Lead troubleshooting and root cause investigations using 5 Whys, Fishbone, and DMAIC for build issues across mechanical, electrical, and software domains.
Mentor engineers and technicians and incorporate technician feedback into processes and documentation.

Desired Qualifications

Experience in an early-stage company or on a first-generation product, standing up processes, lines, and documentation from scratch.
A mechatronics background, including comfort reading electro-mechanical schematics and debugging integrated mechanical, electrical, and software systems.
Experience with motors, encoders, brakes, sensors, and motion control assemblies.
Scripting and data analysis skills using Python, MATLAB, or similar tools.
Experience with supplier qualification, outsourced special processes, and first article inspection.
Familiarity with lean manufacturing principles and line design.

There is no playbook for what we're building. Capstan is bringing a first-of-its-kind surgical robot to
patients, and the processes to build it reliably at scale don't exist yet – you'll help create them. This isn't
sustaining a mature product on a settled line. You'll join a newly formed team that works hand in hand
with R&D owning the productization elements of the design.

In this role, you'll lead the productization of new robotic subsystems – from early engineering builds,
through a series of pre-DV builds, to DV and clinical production. You'll develop the build and test
processes, special processes, fixtures, and documentation that turn a design into a repeatable product,
and you'll use each build to find and close gaps before they reach the line. You'll thrive here if you've
brought complex electro-mechanical systems into production before, love being on the floor with the
hardware, and want to shape how a novel robot is built from day one.

If you're a driver who seeks out issues, converges the team on solutions, and excels at pushing projects
across the finish line in a growth-stage company, this is the role for you.

Key Responsibilities:

• Lead the productization of new robotic subsystems, partnering with R&D from early engineering
builds through pre-DV, DV, and clinical builds
• Own the path from design to product – drive open issues, decisions, and actions to closure
across R&D, Quality, Supply Chain, and Manufacturing, and escalate risks early to keep builds on
schedule
• Plan and drive build readiness for each development build – documentation, fixtures, materials,
equipment, line setup, and training – and use each build to find and close gaps before the next
• Develop and characterize special processes (eg. adhesive bonding and curing, welding, press fits,
crimping), including surrogate testing and DOEs
• Create and mature manufacturing documentation, including MPIs, DHRs, and in-process
inspection points, from redline drafts to released procedures
• Design, qualify, and release assembly fixtures, tooling, and equipment, and define calibration
and preventive maintenance needs
• Provide DFM/DFA feedback early in development, including error-proofing (poka-yoke) features,
to make designs easier to build, test, and service
• Define line layout, process flow, cycle time, and staffing needs for new products, including
facility, utility, safety, and environmental requirements
• Make make-vs-buy decisions for processes and partner with suppliers on outsourced processes
and critical components
• Establish traceability and serialization for assemblies and components, and firmware/software
versions
• Own process risk management (PFMEA) and drive process capability (Cpk) and process
validation plans with Quality
• Partner with manufacturing software engineers to integrate test, calibration, and firmware
loading into the build flow
• Lead troubleshooting and root cause investigations (5 Whys, Fishbone, DMAIC) on build issues
across mechanical, electrical, and software domains
• Mentor engineers and technicians, and incorporate technician feedback into processes and
documentation

What you'll need:

• Bachelor's or Master's degree in Mechanical Engineering, Manufacturing Engineering,
Mechatronics, Electrical Engineering, or related field
• Minimum 7 years of manufacturing engineering experience for Senior, or 10+ years for Staff (a
Master's degree can offset years of experience)
• Proven track record bringing complex electro-mechanical systems from development into
production (robotics, medical capital equipment, or similar)
• Hands-on experience developing special processes (eg. bonding, welding, press fits, crimping)
• Experience designing and qualifying fixtures and tooling using CAD (SolidWorks or similar)
• Working knowledge of process controls and statistics (DOE, Cpk, Gage R&R) and process risk
tools (PFMEA)
• Demonstrated success leading root cause investigations and implementing design and process
fixes
• Experience working in a regulated environment (eg. ISO 13485, 21 CFR 820)
• Excellent communication and documentation skills, and comfortable leading cross-functional
teams
• Strong project leadership: able to plan, drive, and close cross-functional work without formal
authority
• Hands-on, detail-oriented, and able to work independently in a fast-paced environment
• Eagerness to learn and push the envelope to bring a novel surgical robotic platform to market

Preferred:

• Experience in an early-stage company or on a first-generation product, standing up processes,
lines, and documentation from scratch
• Mechatronics background: comfortable reading electro-mechanical schematics and debugging
integrated mechanical, electrical, and software systems
• Experience with motors, encoders, brakes, sensors, and motion control assemblies
• Scripting and data analysis skills (Python, MATLAB, or similar)
• Experience with supplier qualification, outsourced special processes, and first article inspection
• Familiarity with lean manufacturing principles and line design

About the Company

Capstan Medical

Catheter-based heart valve replacement via robotics

Capstan Medical develops catheter-based heart valve replacement tools that use surgical robotics to guide valve implants through blood vessels, avoiding open-heart surgery. Its system combines implants, delivery catheters, and robotic navigation to treat mitral and tricuspid valve disease with minimally invasive techniques. It differentiates itself by integrating robotic guidance with catheter delivery to perform valve replacements without large incisions, aiming for safer, quicker recoveries. Its goal is to provide less invasive, effective treatments for structural heart disease.

Company size: 51-200
Company stage: Series C
Total funding: $141.4M
Headquarters: Santa Cruz, CA
Founded: 2020

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