Robotics Manufacturing Lead – Productization & Scale-Up

Capstan Medical, Inc.; United States; Vor Ort; USD 120.000 - 170.000; Vollzeit

Zusammenfassung

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.

Qualifikationen

• 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.

Aufgaben

• 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.

Kenntnisse

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

Ausbildung

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

Tools

CAD (SolidWorks or similar)

Jobbeschreibung

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.