Senior Manufacturing Engineer

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Thông tin tuyển dụng

1. Nơi làm việc: Bình Dương
2. Ngành nghề: Sản xuất / Vận hành sản xuất , Y tế / Chăm sóc sức khỏe
3. Cấp bậc: Nhân viên
4. Hình thức làm việc: Nhân viên chính thức
5. Mức lương: Thỏa thuận

 

Mô tả công việc

• Coordinate with US Engineering and related cross function Teams to deploy ECN, SCN, CO for Engineering Design Change;
• Design and Develop Manufacturing Processes, tools, and fixtures.;
• Train and supervise production staff on new process and methodology;
• Execution of Process and Equipment Verification and Validation, IQ/OQ/PQ;
• Creation and modification of manufacturing work instructions and process documents for assembly, integration and testing of instrument production;
• Continuous improvement of production process through tooling and fixtures design for increased quality, productivity, efficiency and cost savings;
• Work collaboratively with appropriate departments/teams to develop product design and tooling processes to ensure efficient production methods;
• Interface with outside vendors to determine product specifications; coordinate purchase of equipment, materials, and/or parts; evaluate products to ensure they meet specifications and quality standards;
• Estimate production times, staffing requirements, and related costs to provide information for management decisions;
• Scoping and evaluation of production automation equipment; 
• Execution and leading process improvements through Gage R&R, Cpk and SPC;  
• Understanding and implementation of Lean Manufacturing, Value Stream Mapping and 5S techniques;
• Professional protocol and report writing;
• Lead and resolve or aid in resolution of production process problems;
• Work with cross function team to maintain compliance with ISO 13485;
• Comply with required regulatory agencies, FDA, CDA, CFDA.

Yêu cầu công việc

• Bachelor’s degree in Manufacturing / Industrial / Mechanical or Electrical Engineering or equivalent required with a Master’s degree preferred;
• Minimum 5 years related manufacturing experience and/or training or equivalent combination of education and experience;
• Minimum 5 years experiences on Industrial Engineering, familiar with all Lean tools and able to deploy Lean manufacturing concepts;
• Minimum 3 years medical device manufacturing experience including foreign medical device manufacturing for regulated products;
• Superb English and Chinese written and oral communication skills;
• Ability to read 2D and 3D part prints and models, electrical schematics, wire harness diagrams and BOM documents;
• Working familiarity with SolidWorks or other CAD applications. Electronics/PCBA debugging, instrument test experiences a plus;
• Experience with process automation and medical device manufacturing tools;
• Working knowledge of lean manufacturing, 5S and ISO quality system methodology.

Kỹ năng công việc cần có

senior manufacturing production validation assembly integration interfaces management automation implementation mapping compliance fda cda training

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