Manufacturing Process Engineer

BOSTON SCIENTIFIC MEDICAL DEVICE (MALAYSIA) SDN. BHD.; Batu Kawan; On-site; MYR 56,000 - 100,000; Full time

Job summary

Boston Scientific Medical Device (Malaysia) Sdn. Bhd.

is seeking a manufacturing engineer to collaborate with R&D and Manufacturing to develop safe, cost-effective, and reliable processes for production and to support smooth transfer of new products into full-scale manufacturing. You will provide technical support for process and equipment design, apply Lean and DFSS tools to improve efficiency, and assist in validation activities across equipment and processes in Penang.

Qualifications

• Bachelor's degree in engineering or related field.
• 2–8 years of experience in manufacturing, medical device, or regulated industry.
• Fundamental understanding of process/product technologies and troubleshooting.
• Ability to support equipment/tooling/material/process selection under guidance.

Responsibilities

• Provide technical support in design, optimization, and troubleshooting of manufacturing processes.
• Assist in selecting and developing new equipment, tooling, and materials with engineering teams.
• Apply DFSS/DMAIC and Lean methods to identify inefficiencies and improve processes.
• Support experimentation and testing to characterize, optimize, and troubleshoot equipment.
• Assist in introducing new equipment/processes, including installation and safety assessments.
• Support process validation activities, including writing FMEAs, validation plans, protocols, and reports.
• Help execute and document validation builds, and compile/analyze validation results.
• Ensure compliance with relevant quality systems and regulatory requirements.
• Provide equipment calibration services, ensuring traceability to recognized calibration standards.
• Act as technical SME for calibration during internal/external audits.
• Manage day-to-day functions of the calibration group.
• Support research and acquisition of new calibration standards/equipment, including cost justifications.
• Develop calibration procedures and train technicians on new methods.
• Guide technicians in performing moderately complex calibrations.
• Support calibration lab needs (e.g., environmental control, new technologies)
• Assist in developing department fiscal year budgets
• Communicate calibration status with Operations ME function
• Drive "Standard Work" practices across calibration activities

Skills

Analytical skills

Teamwork

Communication

Problem-solving

Education

Bachelor's Degree in Engineering (Mechanical, Chemical, Biomedical, or related field)

Job description

BOSTON SCIENTIFIC MEDICAL DEVICE (MALAYSIA) SDN. BHD. 4.2 View all jobs

About the Role

Working under supervisory guidance, collaborate with R&D and Manufacturing teams to develop safe, cost-effective, and reliable manufacturing processes, equipment, and products, while supporting smooth transfer of new products/processes into full-scale production.

Key Responsibilities

• Provide technical support in the design, optimization, and troubleshooting of manufacturing processes and equipment
• Assist in selecting and developing new equipment, tooling, and materials with engineering teams and vendors
• Apply problem-solving tools (e.g., DFSS/DMAIC) and Lean methodologies to identify inefficiencies and improve processes
• Support experimentation and testing to characterize, optimize, and troubleshoot equipment and processes
• Assist in introducing new equipment/processes, including installation, calibration, safety (EHS) assessments, and documentation
• Support process validation activities, including writing FMEAs, validation plans, protocols, and reports
• Help execute and document validation builds, and compile/analyze validation results
• Ensure compliance with relevant quality systems and regulatory requirements

Additional Responsibilities (For Calibration-Assigned Role Only)

• Provide equipment calibration services, ensuring traceability to recognized calibration standards
• Act as technical SME for calibration during internal/external audits
• Manage day-to-day functions of the calibration group
• Support research and acquisition of new calibration standards/equipment, including cost justifications
• Develop calibration procedures and train technicians on new methods
• Guide technicians in performing moderately complex calibrations
• Support calibration lab needs (e.g., environmental control, new technologies)
• Assist in developing department fiscal year budgets
• Communicate calibration status with Operations ME function
• Drive "Standard Work" practices across calibration activities

Job Requirements

• Bachelor's Degree in Engineering (Mechanical, Chemical, Biomedical, or related field)
• 2–8 years of relevant experience in manufacturing, medical device, or regulated industry
• Fundamental understanding of process/product technologies and ability to support development, optimization, validation, and troubleshooting
• Ability to provide technical input (under guidance) for equipment, tooling, material, and process selection/development
• Knowledge of problem-solving methodologies, process improvement techniques, and root cause analysis
• Strong analytical, communication, and teamwork skills in a cross-functional environment
• Familiarity with quality systems and regulatory requirements is an advantage

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.