Boston Scientific Senior Manufacturing Engineer 

Malaysia, Penang 

896166785

Job 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.

Job Requirements:

• 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.