Boston Scientific Senior Manufacturing Engineer 

Malaysia, Penang 

854974327

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. Preferable in mechanical, Chemical or biomedical.

• Candidate require has at least 8 years of experience in related field.

• Prefer candidate from medical device or other regulated industry experience.

• Demonstrate ability to generate manufacturing documentations, specifications and technical reports in a concise manner, hands on and action-oriented engineer with strong analytical skill.

• Excellent communication skills.