Medical Injection Molding Engineer - Process & Validation

B Braun; Bayan Lepas; On-site; MYR 90,000 - 130,000; Full time

Job summary

Jora Malaysia seeks an experienced Process Development Engineer to advance injection molding programs for medical devices in Penang. You will develop processes for existing and new molds, train technicians, and drive trials for optimization and cost savings.

Collaboration with R&D and project teams will be essential as you implement ISO 13485 compliant practices. Applicants should have an engineering degree and hands-on mold experience in medical molding, with strong analytical and

Qualifications

• A relevant engineering or technical degree is preferred.
• Proven hands-on experience in injection molding within the medical device industry.
• Strong motivation to continuously learn and grow in medical molding technologies.
• Demonstrated ability to work with R&D and project teams on design and material modifications.
• Capable of leading technicians with strong analytical and troubleshooting skills.
• Familiarity with ISO 13485 standards and requirements for medical device manufacturing.

Responsibilities

• Perform Process development on existing and new molds in a systematic manner, balancing mold, material, machine, and equipment against specs and performance.
• Train and educate technicians so knowledge is shared across molding processes.
• Mold and material trials to optimize projects, cost-saving, and R&D.
• Troubleshoot issues and new projects to fit best solution considering total setup.
• Analyze test data using statistical tools to derive precise conclusions.
• Document and file investigations and results for easy access later.
• Read and interpret specifications and translate into daily work.
• Lead and execute a comprehensive Validation Project (FAT, SAT, IQ, OQ, PQ).
• Drive MDR and ISO project completion (e.g., process studies, verification, PS, MAC, and CP monitoring).

Skills

Injection molding

Medical device

ISO 13485

Statistical analysis

Troubleshooting

Education

Bachelor's degree in Engineering

Tools

SolidWorks

Moldflow

Moldex3D

Minitab

Job description

Jora Malaysia seeks an experienced Process Development Engineer to advance injection molding programs for medical devices in Penang. You will develop processes for existing and new molds, train technicians, and drive trials for optimization and cost savings.

Collaboration with R&D and project teams will be essential as you implement ISO 13485 compliant practices. Applicants should have an engineering degree and hands-on mold experience in medical molding, with strong analytical and