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Sr/Staff Manufacturing Engineer, Robot Productization

Capstan Medical
23 hours ago
Full-time
On-site
Santa Cruz, United States
Indeed

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 regu…

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