(Senior) Process Development Engineer

该职位来源于猎聘 Key Responsibilities

• Applies technical knowledge to innovate, design, and develop processes, procedures, tooling and/or automation.
• Develop and document processes, methods, tooling, and production controls for new programs.
• Provide Design for Manufacturability (DFM) input to the engineering print package.
• Executes the functional deliverables associated with the PDP/TDP, Project Management, and Quality Systems.
• Plans, organizes, and conducts all aspects of technical reviews.
• Ensures proper documentation is completed to meet quality systems requirements (e.g., BOM’s, Routers, FMEA’s, etc.).
• Writes and reviews validation protocols and reports applicable to new processes.
• Oversees development builds associated with the project using special work requests.
• Contributes ideas to or generates Intellectual Property submissions.
• Trains and/or provides work direction to technicians and engineers and may train manufacturing personnel when required as part of a validation.
• May serve as a core team member or extended team member on new product projects.
• Ensures that all aspects of the quality system are the first priority in all activities (e.g., validation protocols, quality plan development, FMEA’s and DCM’s).
• Assesses process capabilities, prioritizes process improvement opportunities, and innovates and implements process improvements on platform or derivative projects.
• Develop qualified production lines.
• Design for manufacture, process optimization (ranging studies) and validation. Technology transfer into manufacturing.
• Manage all phases of equipment qualifications and process validations (protocols, data analysis, reports).
• Conduct test method validations (Gage R&R). Requirements
• Solid mechanical background, master or bachelor’s degree in Mechanical Engineering.
• 5 - 10 years of experience in mechanical design for Senior position. Disposable medical product ，device development experience is preferred.
• Good experience with Geometric Dimensioning and Tolerance (GD&T), Design for Manufacturing(DFM), Tolerance Stack Up Analysis.
• Be familiar with SolidWorks.
• Be familiar with different process for Process engineer.
• Familiar with common engineering materials and corresponding manufacturing technology (e.g. Plastic parts, metal-sheet parts, Die-casting and machining parts etc.)
• Ability to work effectively in complex projects; With innovation skills and problem-solving skills.
• Team player with good interpersonal/intercultural skills.