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Ultrasonic Cleanline Engineer

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Randstad

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Location:
Malaysia , Kuala Lumpur

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Category:
Manufacturing

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Contract Type:
Not provided

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Salary:

5500.00 - 8000.00 MYR / Month
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Job Description:

Exciting Opportunity: Ultrasonic Cleanline Engineer (Medical Device). Are you an innovative problem-solver with a passion for precision and hands-on technical challenges? We are representing a global leader in the medical device industry seeking a skilled Ultrasonic Cleanline Engineer to join their dynamic team. In this role, you will be at the heart of the product lifecycle from developing cleaning processes to ensuring the sterile integrity of life-changing orthopedic implants.

Job Responsibility:

  • Process Development: Lead the creation, optimization, and continuous monitoring of cleaning and passivation processes
  • Validation Leadership: Manage the full validation lifecycle (IQ/OQ/PQ) for cleaning equipment and purified water systems
  • Sterilization & Compliance: Oversee sterilization processes (EO, radiation) and packaging validation to ensure strict compliance with FDA, NMPA, and ISO 13485 standards
  • Continuous Improvement: Spearhead deviation investigations and root cause analysis to enhance process reliability
  • Cross-functional Collaboration: Partner with R&D, Quality, and Production teams for seamless new product process transfers

Requirements:

  • Bachelor's degree or higher in Mechanical, Materials, Chemical, or Biomedical Engineering
  • Minimum of 5 years in medical device process engineering
  • At least 2 years of direct experience in orthopedic implant cleaning processes
  • Deep understanding of machining contaminants, cleanroom operations, and validation lifecycles
  • Fluent in English and Mandarin

Additional Information:

Job Posted:
May 18, 2026

Expiration:
June 26, 2026

Employment Type:
Fulltime
Work Type:
On-site work
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