Manufacturing Engineer
Core
Design, simulate, build, test, and document production tools, test equipment, and processes for manufacturing ophthalmic surgery devices.
Role type
Manufacturing Engineer (Medical Devices)
Builds
Production tools, test equipment, and process improvements for ophthalmic surgery units
Domain
Medical Technology / Ophthalmic Surgery
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
(electro)mechanical problem solving, process data analysis (DOE), risk management (PFMEA), CAD design (2D/3D), Lean principles, process documentation, supplier collaboration
Preferred skills
Green Belt certification, Minitab, RCA/DMAIC/5 Why/Ishikawa methodologies, experience with ISO 13485/21 CFR Part 820
Technologies
AutoCAD, Solid Works, Minitab
Responsibilities
Develop and improve production processes and documentation, investigate nonconformances and manage CAPA, validate machines and processes (FAT, SAT, IQOQPQ), analyze process data to drive yield and efficiency improvements, train and supervise production personnel, prepare risk analyses for assembly and test processes
Seniority
Mid-level, hands-on IC