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Senior Manufacturing Engineer

Senior Manufacturing Engineer

Boston Scientific GruppeGeorge Town, Malaysia
30+ days ago
Job description

Press Tab to Move to Skip to Content Link Select how often (in days) to receive an alert : Create Alert 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 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

Requirements Minimum Degree in Engineering 9-12 years of experience in manufacturing / process engineering. Prior experience in the medical device industry is preferred. Required skills : Problem Solving, analytical skill, project management, critical thinking, NPI, people leadership, direct reports management. Proven track record in product transfers, equipment qualification, and process validation. Experience in working within a matrix organization and cross-site collaboration. Strong project management and technical documentation skills. Proficient in validation protocol / report writing (IQ / OQ / PQ). Skilled in root cause analysis and process improvement methodologies . Effective communication and stakeholder management across global teams Experience in product transfer will be added advantage. About Us As a global medical technology leader for more than 40 years, our mission at Boston Scientific (NYSE : BSX) is to transform lives through innovative medical solutions that improve the health of patients. If you’re looking to truly make a difference to people both around the world and around the corner, there’s no better place to make it happen.

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Manufacturing Engineer, Medical Device Engineer, Medical Device, CAPA, Engineering, Healthcare, Management, Manufacturing

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Manufacturing Engineer • George Town, Malaysia

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