Senior Manufacturing Process Engineer

Boston Scientific; Seberang Perai; On-site; MYR 90,000 - 120,000; Full time

Job summary

Boston Scientific in Malaysia is seeking a Manufacturing Engineer II to drive manufacturing engineering duties for CGMP-compliant production. You will develop and modify documentation, ensure new product introductions meet quality and cost goals, and lead process improvements across manufacturing operations.

The role requires 5–8 years in manufacturing or process engineering, strong data analysis skills, and knowledge of validation methodologies.

Qualifications

• Bachelor's Degree in Engineering or related field.
• 5-8 years of relevant experience in manufacturing or process engineering.
• Hands-on experience in process improvement, problem-solving, and engineering support.
• Proficient in data analysis, SQL, Microsoft Excel, and other Microsoft Office applications.
• Knowledge of validation processes and engineering methodologies.

Responsibilities

• Identify, order and commission 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

Skills

Data analysis

SQL

Excel

Education

Bachelor's Degree in Engineering

Job description

Boston Scientific in Malaysia is seeking a Manufacturing Engineer II to drive manufacturing engineering duties for CGMP-compliant production. You will develop and modify documentation, ensure new product introductions meet quality and cost goals, and lead process improvements across manufacturing operations.

The role requires 5–8 years in manufacturing or process engineering, strong data analysis skills, and knowledge of validation methodologies.