Medical Device Process Engineer - Optimize Production

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.

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.