Senior Manufacturing Engineer

Ability to coach, lead and enhance the productivity of technical reports within the business. Candidate 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. 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. Provide a structured framework for training of technical reports. Build collaborative relationships through strong teamwork across the organization. To identify, order and commission the key process equipment to CGMP in the Operations Engineering Cycle to meet key business objectives Engineering process owner for the area. Develop and modify manufacturing documentation and procedures to support commercial products as well as the introduction of new products to the production floor (assembly procedures, BOMs, etc.) Ensure that new products introduced to the production floor meet business, quality, output and cost goals and objectives Develop and modify various manufacturing processes to improve product and process quality and output Ensure product/process requirements are met for component, assembly, tooling and supplier specifications Perform product/process/vendor qualification activities as required Support material discrepancy review and disposition activities (MRB) for existing commercial products Develops knowledge in a field to become a recognized leader or authority in an area of specialization and applies this knowledge in leadership roles in the company. Eliminate/reduce product/process defects and improve yields. Strong problem solver for technical problems in the area, solves problems from basic engineering principles, theories and concepts. Demonstrate a primary commitment to patient safety and product quality Support all quality and corrective/preventive actions initiatives (NCEP, CAPA) to achieve quality goals Maintain a valid capacity model in co-operation with the line Supervisor and conduct adequate advance planning for required capital Capable of training cross functional team members including, engineers, technicians and product builders Knowledge of project management. Interacts cross functionally and with internal and external customers. Ability to develop expert knowledge on BSC systems. Willing to travel internationally as part of project team. For individual who is assigned calibration engineering role only: Provide equipment calibration services necessary to meet company objectives, while assuring measurement traceability to nationally recognized equipment calibration standards and practices. Technical SME for Calibration group and SME for internal and external Audit. SME for Calibration Management System. Perform calibration functions and sets day to day function for calibration group. Researches, recommends, and acquires new standards and other capital equipment, providing detailed justifications and cost analysis as required. Develops technical engineering reports and complex technical calibration procedures and trains department technicians on new calibration procedures. Works directly with Equipment Engineering and Manufacturing Engineering departments to advise on equipment selection, design accommodations for calibration of new equipment and appropriate measurement techniques. Provides support and guidance to calibration technicians in performing complex equipment calibrations. Supports calibration lab needs regarding such issues as environmental control and new technologies. Works with Management to develop the department fiscal year budgets. Communicates with the Operations ME function on calibration status. Build Quality into all aspects of work by maintaining compliance to all quality requirements. Drive “Standard Work” in all aspect of Calibration activity.