Senior Process Development Engineer

Manages and leads complex projects independently with minimal supervision. 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'. Write and perform process validations (IQ, OQ, PQ/PPQ) and validate methods for inspection for verification and process controls. Interface directly with assemblers, production supervisors, leads, engineers and management daily. Coordinate with the suppliers and external resources needed in developing and implementing new process/product plans. Work as part of a development team in developing and implementing new devices. Facilitate excellent communications between all team members. Assesses process capabilities, innovates and implements process improvements on key projects with divisional impact. Applies technical knowledge to innovate, design, and develop processes, procedures, tooling and/or automation. Executes the functional deliverables associated with the PDP, Design Control, CAPA, and all Quality Systems. As needed; plans, organizes, and participate all aspects of technical reviews. Collaborate to ensure proper documentation is completed to meet quality systems requirements. (e.g., GOIs, BOM's, Routers, FMEA's, etc.) Candidates require process at least Bachelor's degree in Mechanical Engineering or Biomedical Engineering or related engineering degree. Candidate require has at least 8 years of demonstrated process development / improvement activities. Process Development; equipment validations and process characterization and validation experience. Prefer candidate from medical device or other regulated industry experience. Required: Six Sigma Black Belt or demonstrated use of Design for Six Sigma tools (DOE, problem solving, process improvement). Demonstrated ability to develop processes from concept to production. Guide and mentor junior on process and product development. Excellent communication skills.