Boston Scientific Senior Manufacturing Engineer 

Malaysia, Penang 

750326353

Key Responsibilities

• 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

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.