We are hiring NPI Engineer/Process Engineer Responsibilities: Develop and implement new manufacturing processes for new disposable medical devices.Perform Design of Experiments for process definition and to optimize equipment parameters for new and/or existing processes.Create documentation to support new and improved manufacturing processes.Use of Six Sigma, Lean, and Mistake proof methodologies in the development of manufacturing processes to implement processes that are 'born lean and capable'.Responsible for the new products implementation. The job including new BOM, and Work Instruction creation, validation run activities coordination.Execute process validation (IQ. OQ, PQ) and validate methods for inspection for verification and process controls during product development stage, perform data analysis and report compilation.Collaborate to ensure proper documentation is completed to meet quality systems requirements. (e.g., GOIs, BOM's, Routers, FMEA's, etc.)Coordinate and execute all relevant engineering change work flow, drawing and documentation update in accordance to the SOP Requirements: Candidates require process at least Bachelor's degree in Mechanical Engineering or Biomedical Engineering or related engineering degree.At least 3-5 year(s) of working experience in manufacturing or project management, preferably in medical device assembly industryProcess Development; equipment validations and process characterization and validation experience. Six Sigma Green Belt or demonstrated use of Design for Six Sigma tools (DOE, problem solving, process improvement).Sound knowledge and practical experience in medical device process validation IQ/OQ/PQGood understanding of legislative standards for medical device i.e. ISO 13485, FDA 21 CFR Part 820, or equivalentTeam player and able to work in fast pace project environment, liaising with multiple project stakeholders working towards aggressive deadlineGood interpersonal and communication with sound presentation skill