About this opportunity
Capstan Medical, Inc. lists this Sr/Staff Manufacturing Engineer, Robot Productization opportunity in aptos, California. Review the employer’s description below for duties, qualifications and application requirements.
Job description
Job Description Job Description 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 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 We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses and identifying potential inconsistencies or verification signals in application materials based on available information. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.
Worksite address
aptos, CA, 95003, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.