Sr/Staff Manufacturing Engineer, Robot Productization

Capstan Medical, Inc.; United States; On-site; USD 120,000 - 170,000; Full time

Job summary

Capstan Medical, Inc. seeks a senior Manufacturing/Process Engineer to lead productization of robotic subsystems from early engineering through DV and clinical builds.

You will coordinate R&D, Quality, Supply Chain, and Manufacturing to keep builds on schedule and drive design-for-manufacturing improvements. Responsibilities include planning build readiness, developing special processes, and maturing manufacturing documentation.

Qualifications

• Bachelor's or Master's in Mechanical/Manufacturing/Mechatronics or related field.
• Minimum experience: Senior 7+ years; Staff 10+ years with master's offset.
• Proven track record bringing complex electro-mechanical systems to production.
• Hands-on in developing special processes (bonding, welding, press fits, crimping).
• Experience designing/qualifying fixtures and tooling using CAD.
• Knowledge of process controls, statistics (DOE, Cpk, Gage R&R), PFMEA.
• Experience in regulated environments (ISO 13485, 21 CFR 820).
• Strong communication, documentation, and cross-functional leadership.

Responsibilities

• Lead productization of robotic subsystems across R&D, Quality, Supply Chain, and Manufacturing.
• Own design-to-product path; drive issues to closure and escalate risks to schedule.
• Plan build readiness: documentation, fixtures, materials, equipment, and training.
• Develop and characterize special processes with surrogate testing and DOEs.
• Create and mature manufacturing documentation from draft to released procedures.
• Design/qualify fixtures and tooling, define calibration and PM needs.
• Provide early DFM/DFA feedback, including poka-yoke features.
• Define line layout, process flow, cycle time, staffing for new products.
• Make make-vs-buy decisions; partner with suppliers on outsourced processes.
• Establish traceability/serialization for assemblies and firmware versions.
• Own PFMEA and drive process capability and validation with Quality.
• Collaborate with manufacturing software engineers to integrate test/calibration/firmware loading.
• Lead root-cause investigations across mechanical, electrical, and software domains.
• Mentor engineers/technicians and incorporate feedback into processes.

Skills

Cross-functional leadership

Project leadership

Communication & documentation

Hands-on, detail-oriented

Root cause investigations

Process improvement

Design for manufacturing

DFM/DFA feedback

Troubleshooting (5 Whys, Fishbone, DMA

Education

Bachelor's or Master's in Mechanical Engineering, Manufacturing Engineering, Mechatronics, Electrical Engineering

Tools

CAD (SolidWorks or similar)

Job description

Key Responsibilities:

• Lead the productization of new robotic subsystems, partnering with R&D from early engineering
  builds through pre-DV, DV, and clinical builds
  across R&D, Quality, Supply Chain, and Manufacturing, and escalate risks early to keep builds on
  schedule
• 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