Sr/Staff Manufacturing Engineer, Robot Productization

Capstan Medical • Santa Cruz, CA

4h

About The Position

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.

Requirements

• 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

Nice To Haves

• 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

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 This Job Offers

• Job Type: Full-time
• Career Level: Senior