Manufacturing Engineer
仕事内容
On-site Manufacturing Engineer owning and improving manual assembly and molding processes for single-use catheter products, with a 60% floor time and 40% desk time split.
Analyze, stabilize, and scale manual/semi-automated processes (injection molding of junction hubs, pad printing, tipping, drilling) with an IQ/OQ/PQ mindset to meet regulatory and quality requirements.
Design and improve tooling and fixtures; collaborate on CAM/CNC workflows; support rapid tool changes on the floor.
Generate clear work instructions, technical reports, and product/test documentation, including biocompatibility strategy inputs, aligned to the quality system.
Drive continuous improvement in a highly manual environment; apply basic statistics (trend charts, Cpk/Ppk) to justify decisions.
Partner closely with the VP of Engineering to accelerate NPI and cleanroom expansion, and contribute to facilities/cleanroom reliability in a small, flexible team.
Analyze, stabilize, and scale manual/semi-automated processes (injection molding of junction hubs, pad printing, tipping, drilling) with an IQ/OQ/PQ mindset to meet regulatory and quality requirements.
Design and improve tooling and fixtures; collaborate on CAM/CNC workflows; support rapid tool changes on the floor.
Generate clear work instructions, technical reports, and product/test documentation, including biocompatibility strategy inputs, aligned to the quality system.
Drive continuous improvement in a highly manual environment; apply basic statistics (trend charts, Cpk/Ppk) to justify decisions.
Partner closely with the VP of Engineering to accelerate NPI and cleanroom expansion, and contribute to facilities/cleanroom reliability in a small, flexible team.
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