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Capstan Medical

Sr/Staff Manufacturing Engineer, Robot Productization

Posted 14 Days Ago
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In-Office
Santa Cruz, CA
Senior level
In-Office
Santa Cruz, CA
Senior level
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.
The summary above was generated by AI
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

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