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Boston Scientific Manufacturing Engineer 
Malaysia, Penang 
558153431

30.08.2024

Job Description:

  • 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.
  • Support all quality and corrective/preventive actions initiatives (NCEP, CAPA) to achieve quality goals
  • 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
  • Manage and Perform calibration functions. 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.
  • Manage calibration lab needs regarding such issues as environmental control and new technologies.
  • Works with Senior Metrology Engineer and 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.

Job Requirements:

  • Bachelor's degree in any related engineering filed.
  • Required at least 5-8 years of working experience.
  • Experiences in Medical Devices Manufacturing Industry could be added advantages.
  • Critical thinking and experienced in applying problem solving and process improvement methodologies such as PDCA & DMAIC.
  • Poses strong collaboration skills and able work effectively with cross-functional team.
  • Skill required: Minitab and Analytical.