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Boston Scientific Medical Device (Malaysia) Sdn. Bhd. in Penang is seeking a Senior Manufacturing Engineer to lead manufacturing engineering duties, drive process improvements, ensure quality and cost goals, and collaborate with cross-functional teams across the organization.
The role requires hands-on, data-driven, goal-oriented execution in a fast-paced environment with NPI and calibration/maintenance activities as needed. International travel may be required.
Manufacturing Engineering Department seeking a Senior Manufacturing Engineer to perform all manufacturing engineering duties. The ideal candidate must possess effective verbal, written presentation, negotiation and interpersonal skills. Demonstrate ability to generate manufacturing documentations, specifications and technical reports in a concise manner, hands on and action-oriented engineer with strong analytical, critical thinking skills and able to work well under general directions with minimum supervision. The candidate should be data driven, goal oriented and willing to learn and development new skills, able to work in a fast paced, time sensitive, multi-project and results driven environment with multi-disciplinary team interface. The ideal candidate must be able to plan and organize non-routine task. Ability to coach, lead and enhance the productivity of technical reports within the business. Provide a structured framework for training of technical reports. Build collaborative relationships through strong teamwork across the organization.
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.
Your work can make a difference.
Imagine knowing that what you do every day contributes to technologies that help improve millions of lives.
For more than 45 years, Boston Scientific has been transforming lives through innovative medical technologies
And Penang is part of that global story.
Our Penang site became first manufacturing facility in Asia, with the plant completed in 2017. Today, we supports manufacturing and APAC regional distribution operations, connecting the work of our local teams with patients & healthcare systems around the world.
Here you can learn, collaborate, innovate & grow while contributing to a purpose bigger than any one role.
Your work can make a difference.
Imagine knowing that what you do every day contributes to technologies that help improve millions of lives.
For more than 45 years, Boston Scientific has been transforming lives through innovative medical technologies
And Penang is part of that global story.
Our Penang site became first manufacturing facility in Asia, with the plant completed in 2017. Today, we supports manufacturing and APAC regional distribution operations, connecting the work of our local teams with patients & healthcare systems around the world.
Here you can learn, collaborate, innovate & grow while contributing to a purpose bigger than any one role.
What can I earn as a Manufacturing Engineer