Senior Device Mechanical Engineer
仕事内容
Lead mechanical design and development of medical devices and small fixtures from concept through prototyping, testing, and manufacturing transfer.
Provide technical leadership to cross-functional teams, ensuring designs are innovative, manufacturable, and user-focused.
Develop detailed CAD models, drawings, and specifications with design for manufacturability and robust verification plans.
Manage complex projects, coordinate timelines, budgets, and quality milestones, and drive root-cause analysis and continuous improvements.
Ensure regulatory compliance (FDA, ISO 13485) and thorough documentation, design history files, and validation protocols.
Lead risk assessments, FMEAs, design reviews, and vendor relations for outsourced prototyping and component sourcing.
Provide technical leadership to cross-functional teams, ensuring designs are innovative, manufacturable, and user-focused.
Develop detailed CAD models, drawings, and specifications with design for manufacturability and robust verification plans.
Manage complex projects, coordinate timelines, budgets, and quality milestones, and drive root-cause analysis and continuous improvements.
Ensure regulatory compliance (FDA, ISO 13485) and thorough documentation, design history files, and validation protocols.
Lead risk assessments, FMEAs, design reviews, and vendor relations for outsourced prototyping and component sourcing.
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