Transfer Process Engineer - Medical Device Manufacturing

Pentamaster Corporation Berhad; Batu Kawan; On-site; MYR 90,000 - 125,000; Full time

Job summary

Pentamaster Corporation Berhad in Malaysia seeks a process engineer to lead the end-to-end transfer of medical device products from external partners to the manufacturing facility, ensuring smooth transitions and strict regulatory compliance.

You'll drive DoE, Six Sigma, and Lean initiatives, develop and validate processes, and coordinate cross-functional teams to ensure quality and on-time product introductions.

Qualifications

• Bachelor's degree in engineering (Mechanical, Electrical, Biomedical, Industrial) or related field.
• 3–5 years of experience in manufacturing or project management, preferably in medical device assembly.
• Experience with design controls, validation protocols (IQ/OQ/PQ), and risk management.

Responsibilities

• Develop and implement new manufacturing processes for new disposable medical devices.
• Perform Design of Experiments for process definition and to optimize equipment parameters.
• Create documentation to support new and improved manufacturing processes.
• Use Six Sigma, Lean, and Mistake proof methodologies to implement lean, capable processes.
• Manage new products implementation including BOM and Work Instruction creation, validation run activities coordination.
• Execute process validation (IQ, OQ, PQ) and validate methods for inspection and process controls.
• Collaborate to ensure proper documentation for quality systems requirements (GOIs, BOMs, Routers, FMEAs, etc.).
• Coordinate and execute engineering change workflows and document updates per SOP.

Skills

Process development

Design of Experiments

Six Sigma

Lean manufacturing

FMEA

CAPA

IQ/OQ/PQ

Documentation

Quality systems

Education

Bachelor's degree in Engineering

Job description

Pentamaster Corporation Berhad in Malaysia seeks a process engineer to lead the end-to-end transfer of medical device products from external partners to the manufacturing facility, ensuring smooth transitions and strict regulatory compliance.

You'll drive DoE, Six Sigma, and Lean initiatives, develop and validate processes, and coordinate cross-functional teams to ensure quality and on-time product introductions.