Senior Manufacturing Engineer

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Recruitment Information

1. Work location: Binh Duong
2. Industry: Manufacturing / Process , Medical / Healthcare
3. Job level: Experienced
4. Job type: Permanent
5. Salary: Negotiable

 

Job description

• 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.

Job Requirement

• 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.

Required Job Skills

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

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