ultrasonic cleanline engineer.

The Impact You Will Make

You will lead the technical rigor required to ensure every product meets the highest safety standards:

• 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.

What You Bring to the Team

We are looking for a technical expert who thrives in highly regulated manufacturing environments:

• Educational Background: Bachelor’s degree or higher in Mechanical, Materials, Chemical, or Biomedical Engineering.

• Industry Experience: Minimum of 5 years in medical device process engineering.

• Specialized Expertise: At least 2 years of direct experience in orthopedic implant cleaning processes.

• Technical Knowledge: Deep understanding of machining contaminants, cleanroom operations, and validation lifecycles.

• Communication Skills: Fluent in English and Mandarin; the ability to use both for technical documentation is essential (Mandarin preferred).