The Role
Lead productization of robotic subsystems from engineering builds through clinical production. Develop and qualify manufacturing processes, fixtures, tooling, documentation, line layouts, and process controls for complex electro-mechanical surgical robots. Drive DFM/DFA, risk management, validation, root-cause investigations, supplier decisions, traceability, and cross-functional issue resolution while mentoring engineers and technicians.
Summary Generated by Built In
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.
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
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
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
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
Skills Required
- 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+ years for Staff level; a Master's degree may offset experience
- Experience bringing complex electro-mechanical systems from development into production
- Hands-on experience developing special processes such as bonding, welding, press fits, and crimping
- Experience designing and qualifying fixtures and tooling using CAD such as SolidWorks
- Working knowledge of DOE, Cpk, Gage R&R, and PFMEA
- Experience leading root-cause investigations and implementing design and process fixes
- Experience working in a regulated environment such as ISO 13485 or 21 CFR 820
- Excellent communication and documentation skills, with the ability to lead cross-functional teams
- Strong project leadership skills, including driving cross-functional work without formal authority
- Hands-on, detail-oriented, independent, and effective in a fast-paced environment
- Experience at an early-stage company or with a first-generation product
- Mechatronics experience, including reading electro-mechanical schematics and debugging integrated 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
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The Company
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.
