NPI Assistant/Engineer

9 hours ago

Simpang Empat, Perak, Malaysia MeHow Medical (M) Sdn Bhd Full time

Role Description

  • 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.

Qualifications

  • Minimum Diploma or Degree in Mechanical 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.
  • Knowledge of mechanical / electrical control.
  • Ability to manage a group of people.
  • Good communication and coordination skills.
  • Must be willing to hands-on and work in plastic injection molding environment.

Job Types: Full-time, Permanent

Benefits:

  • Free parking
  • Health insurance
  • Meal allowance
  • Professional development

Ability to commute/relocate:

  • Simpang Ampat: Reliably commute or planning to relocate before starting work (Preferred)

Application Question(s):

  • What's your expected monthly basic salary?

Language:

  • Mandarin (Preferred)

Work Location: In person

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