Injection Molding Engineer (NPI, Mold Trials, Medical Industry)

Job Responsibilities:

Lead and manage the end-to-end NPI process for plastic injection molded components and assemblies.

Plan and execute mold trials (T0, T1, etc.) and validation runs (IQ, OQ, PQ) to qualify tools and processes.

Develop and optimize injection molding parameters and process documentation (WI, SOP, etc.).

Work with tooling engineers, process engineers, and QA to resolve dimensional, cosmetic, or functional issues.

Identify and mitigate risks during the product ramp-up.

Monitor project timelines, budgets, and ensure successful project handover to mass production.

Drive continuous improvement initiatives based on lessons learned from NPI cycles.

Analyze trial reports, implement corrective actions, and drive process improvements.

Ensure compliance with quality and regulatory standards (ISO, FDA, etc. as applicable).

Provide training and support for production engineers and technician.

Ensure compliance with company quality standards (ISO 9001 / ISO 13485)

Report problems or concerns with quality, processes, equipment, materials to superior.

To perform ad-hoc tasks assigned by superior.

Requirements:

Minimum Diploma or Degree in Mechanical / Polymer / Materials Engineering or equivalent.

Minimum 5 years of working experience in plastic injection molding or related field.

Understand of 5S Management, QMS, ISO 13485 procedures and requirements.

Ability to manage a group of people.

Root Cause analysis.

Good communication and coordination skills.

Must be willing to hands-on and work in plastic injection molding environment.

Able to work independently with minimum supervision.