Sterilization Engineer

Job Title: ETO Sterilization Medical Device Engineer

Overview: We are seeking an experienced ETO Sterilization Medical Device Engineer to join our team. This role focuses on the development, validation, and optimization of ethylene oxide (ETO) sterilization processes for medical devices, ensuring compliance with regulatory standards and quality requirements.

Key Responsibilities:

• Design, validate, and optimize ETO sterilization processes for a variety of medical devices.
• Collaborate with R&D, manufacturing, and quality teams to ensure sterilization methods are integrated into product development and production processes.
• Conduct risk assessments and develop validation protocols to ensure compliance with FDA, ISO, and other regulatory requirements.
• Analyze sterilization data and trends to identify areas for process improvement.
• Troubleshoot and resolve issues related to ETO sterilization processes and equipment.
• Prepare and maintain documentation related to sterilization process specifications, validation reports, and standard operating procedures.
• Train personnel on ETO sterilization protocols and best practices.

Qualifications:

• Bachelor’s degree in Biomedical Engineering, Chemical Engineering, or a related field.
• 3+ years of experience in medical device sterilization, specifically with ETO processes.
• Strong knowledge of regulatory requirements (FDA, ISO) related to sterilization and medical devices.
• Familiarity with sterilization validation methodologies and data analysis.
• Excellent problem-solving skills and attention to detail.
• Strong communication and teamwork abilities.

Preferred Skills:

• Experience with sterilization equipment and process optimization.
• Knowledge of other sterilization methods (e.g., gamma, steam) is a plus.
• Project management experience is desirable.