Medical Molding Engineer – Process & Validation Leader

B. Braun Medical Industries Sdn. Bhd.; Bayan Lepas; On-site; MYR 60,000 - 96,000; Full time

Job summary

B. Braun Medical Industries Sdn Bhd in Penang seeks a process development engineer focusing on medical device molding. You will optimize existing molds and lead process development projects, balancing mold, materials, machines, and equipment against specifications and data.

You will train technicians, contribute to MDR/ISO initiatives, perform data analysis with Minitab, and document investigations. Collaboration with R&D and QA to translate requirements into daily operations is essential.

Qualifications

• Relevant engineering/technical degree preferred.
• Hands-on injection molding experience in medical devices.
• Strong motivation to learn and grow in medical molding.
• Ability to work with R&D and project teams on design/material modifications.
• Capable of leading technicians with analytical and troubleshooting skills.
• Familiarity with ISO 13485 standards for medical device manufacturing.

Responsibilities

• Perform Process development on molds balancing mold, material, machine, and equipment against specs, measurements, and performance.
• Train technicians to share knowledge across molding processes.
• Mold and material trials to optimize projects and cost-saving initiatives.
• Troubleshoot issues and new projects for optimal solutions and total setup.
• Analyze test data using statistical tools to reach precise conclusions.
• Document investigations and results for easy future access.
• Interpret specifications and translate into daily work with broader perspective.
• Lead and execute validation projects (FAT, SAT, IQ, OQ, PQ).
• Drive MDR and ISO project completion (process studies, verification, monitoring).

Skills

Analytical mindset

Team leadership

Problem solving

Reading specifications

Education

Engineering degree or technical diploma

Tools

SolidWorks

Moldflow

Moldex3D

Minitab

Job description

B. Braun Medical Industries Sdn Bhd in Penang seeks a process development engineer focusing on medical device molding. You will optimize existing molds and lead process development projects, balancing mold, materials, machines, and equipment against specifications and data.

You will train technicians, contribute to MDR/ISO initiatives, perform data analysis with Minitab, and document investigations. Collaboration with R&D and QA to translate requirements into daily operations is essential.