Senior Manufacturing Engineer


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 analysis implementation production planning training teamwork dfm fda