Sr/Staff Manufacturing Engineer, Robot Productization

Capstan Medical, Inc.•Santa Cruz, CA

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