Engineering Manager

2 days ago

Klang, Selangor, Malaysia Ambition Full time 80,000 - 120,000 per year

Key Responsibilities:

  • Ensure full compliance with ISO 13485, GMP, and relevant product and regulatory standards.
  • Lead new product introduction (NPI) and improvement projects, including technical support for manufacturing and customers.
  • Oversee material evaluation, process development, validation, and revalidation activities.
  • Monitor machine downtime and ensure optimal performance of production equipment.
  • Drive process efficiency, preventive maintenance programs, and Lean Manufacturing initiatives.
  • Manage and deliver process engineering and improvement projects on time and within budget.
  • Lead cost reduction and process optimization programs across operations.
  • Evaluate competitor products and stay updated with the latest technological advancements.
  • Review and assess change requests from suppliers and customers to ensure quality and compliance.

Key Requirements:

  • Bachelor's Degree in Engineering, Science, or a related technical discipline.
  • Minimum 5 years of experience in engineering management, project management, or R&D—preferably in moulding, assembly, or automation processes.
  • Experience in an ISO 13485-certified manufacturing environment is an advantage.
  • Strong knowledge of ISO 13485, FDA 21 CFR Part 820, and GMP requirements.
  • Innovative, proactive, and able to work independently with minimal supervision.

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