Senior Manufacturing Engineer

Boston Scientific Corporation; Batu Kawan; On-site; MYR 120,000 - 160,000; Full time

Job summary

Boston Scientific Corporation in Batu Kawan, Penang, Malaysia, seeks an experienced Manufacturing Engineer to lead engineering cycles, commission key process equipment to CGMP, and own the manufacturing processes on the shop floor.

The role emphasizes NPI, process improvement, calibration where needed, MRB/CAPA collaboration, and cross-functional training with international travel as required.

Qualifications

• Bachelor’s degree in Engineering (Mechanical, Chemical or Biomedical preferred).
• Minimum 9 years of Manufacturing Engineering experience.
• Experience with equipment commissioning/qualification and new product introduction (NPI).
• Strong problem-solving, analytical, and communication skills.
• Experience with MRB, CAPA, NCEP/nonconformance, and root cause analysis.

Responsibilities

• Identify, order and commission key process equipment to CGMP in the Operations Engineering cycle.
• Act as engineering process owner for the area.
• Develop and modify manufacturing documentation to support commercial products and new product introductions.
• Ensure new products meet business, quality, output and cost goals.
• Improve product and process quality and output through process development.

Education

Bachelor’s Degree in Engineering

Tools

Lean Six Sigma

Kaizen

Project management

Analytical thinking

Communication skills

Job description

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
• 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:

• Bachelor’s Degree in Engineering, preferably Mechanical, Chemical, or Biomedical Engineering.
• Minimum 9 years of Manufacturing Engineering experience.
• Able to independently manage manufacturing processes with minimal supervision.
• Experience in equipment commissioning/qualification and new product introduction (NPI).
• Proven experience improving yield, output, quality, productivity, or cost.
• Experience with MRB, CAPA, NCEP/nonconformance, and root cause analysis.
• Knowledge of Lean, Six Sigma, and Kaizen with experience leading process improvement activities.
• Experience in capacity planning, project management, and cross-functional collaboration/training.
• Strong problem-solving, analytical, communication, and technical documentation skills.
• Willing to travel internationally when required.
• Calibration experience is required only for calibration-related assignments.

For more than 45 years, Boston Scientific has advanced innovative medical technologies to help improve lives. At our Batu Kawan facility in Penang, we're gearing up for an exciting new chapter with new product lines, creating opportunities for passionate talent to help bring the next wave of medical innovation to life.

Job Segment:

Manufacturing Engineer, Biomedical Engineering, Facilities, Lean Six Sigma, Six Sigma, Engineering, Operations, Management