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A global leader in the medical device industry is seeking a highly skilled Senior Cleanline or Sterilization Engineer to join our team. This role is critical in ensuring the safety, compliance, and integrity of life-saving medical products through advanced cleaning and sterilization processes.
Job Responsibility:
Lead the development and continuous monitoring of cleaning processes, including passivation and chemical efficiency
Manage the entire lifecycle of cleaning machines and purified water systems, including IQ/OQ/PQ to maintain a validated state
Lead the validation and daily monitoring of sterilization processes such as Ethylene Oxide (EO) and Radiation
Validate finished product packaging processes, including seal integrity testing and transportation simulations
Evaluate the impact of sterilization on implant material performance and packaging system functionality
Oversight of detergents, filter bags, and ultrasonic baskets, including performance monitoring and replacement cycles
Lead deviation investigations, root cause analysis (RCA), and maintain technical documentation and SOPs to support audits
Requirements:
Bachelor’s degree or higher in Mechanical, Materials Science, Chemical, or Biomedical Engineering
5 years in medical device process engineering
2 years specifically focused on orthopedic implant cleaning processes
Deep understanding of upstream machining processes, contaminant characteristics, and cleanroom operation requirements
Proficient in the cleaning validation lifecycle, cleanliness testing methods, and sterilization regulatory standards
Hands-on experience in the maintenance and performance revalidation of sterilization and cleaning equipment