Sr/Staff Manufacturing Engineer, Robot Productization

About the job

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.

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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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