Sr/Staff Manufacturing Engineer, Robot Productization
Capstan Medical · Santa Cruz, California, United States · onsite
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