Manufacturing Engineer

About the role

The Manufacturing Engineer will support new product development and mass production of high‑precision medical device components. The role involves reviewing designs, optimizing CNC processes, and ensuring compliance with ISO13485 and GMP standards.

Key responsibilities

• Review 2D drawings and 3D models in R&D, provide DFM optimization suggestions, and produce feasibility reports.
• Design process schemes, select tools, and optimize cutting parameters for 5‑axis milling, Swiss turning, grinding, wire EDM, turning, gun drilling and other CNC equipment.
• Perform CAM programming and simulation using UG/NX, Esprit or Mastercam, and support prototype trials and first‑piece validation.
• Organize multi‑round trial production, collect and analyze process data, and create SOPs and work instructions for smooth design‑to‑process transfer.
• Design and select CNC tooling and fixtures, optimize clamping and positioning to reduce deformation and improve consistency.
• Collaborate with quality, production, R&D and purchasing teams to resolve technical issues, conduct equipment IQ/OQ/PQ verification, and maintain ISO13485 compliance.

Required profile

• Minimum 3 years of CNC machining experience, preferably with stainless steel, titanium alloy, medical‑grade plastics and PEEK.
• Experience in the medical device industry and familiarity with GD&T standards and full NPI process.
• College degree or higher in mechanical technology, material processing or related field.
• Strong analytical, problem‑solving and technical writing skills, with fluent English reading and writing.

Required skills

• CNC machining (5‑axis milling, Swiss turning, grinding, wire EDM, gun drilling)
• CAM programming and simulation (UG/NX, Esprit, Mastercam)
• DFM optimization, tool selection, cutting parameter optimization
• GD&T, ISO13485, GMP compliance
• Quality analysis tools (A3, 8D)