Senior Mechanical Engineer
仕事内容
Lead the mechanical design, development, and optimization of complex medical devices and combination products from concept through manufacturing transfer.
Provide technical guidance to junior engineers and collaborate with electrical, software, systems, and manufacturing teams to ensure integrated product development.
Develop prototypes, perform testing and validation, and conduct root cause analysis to resolve technical challenges.
Drive design and phase-gate reviews, ensuring compliance with ISO 13485 and applicable regulatory standards, while maintaining comprehensive documentation.
Apply CAD tools (SolidWorks or equivalent), FEA/CFD simulations, and knowledge of materials and manufacturing methods to deliver robust designs.
Manage multiple projects with competing priorities in a regulated environment, with minimal travel and no supervisory responsibilities.
Provide technical guidance to junior engineers and collaborate with electrical, software, systems, and manufacturing teams to ensure integrated product development.
Develop prototypes, perform testing and validation, and conduct root cause analysis to resolve technical challenges.
Drive design and phase-gate reviews, ensuring compliance with ISO 13485 and applicable regulatory standards, while maintaining comprehensive documentation.
Apply CAD tools (SolidWorks or equivalent), FEA/CFD simulations, and knowledge of materials and manufacturing methods to deliver robust designs.
Manage multiple projects with competing priorities in a regulated environment, with minimal travel and no supervisory responsibilities.
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