EO Sterilization Engineer II - Validation & Process

Medtronic Singapore Operations Pte Ltd; Singapore; On-site; SGD 70,000 - 110,000; Full time

Job summary

Medtronic Singapore Operations Pte Ltd in Singapore is seeking a Sterilization Engineer II to support EO sterilization validation, process control, and continuous improvement within Sterility Assurance. You will partner with manufacturing, quality, microbiology, packaging, and regulatory teams to ensure compliance and robust sterilization programs across the product lifecycle.

Based in Singapore with an onsite work arrangement, the role focuses on leading validation activities, developing

Qualifications

• Bachelor's degree in a related field with 2+ years in sterility/sterilization or medical device manufacturing.
• Experience with Ethylene Oxide (EO) sterilization, validation, and process controls.
• Knowledge of ISO 11135, ISO 13485, FDA requirements and sterilization standards.
• Experience creating validation documentation and QMS records.
• Excellent written and spoken English.

Responsibilities

• Lead sterilization validation and requalification activities for EO processes in accordance with regulatory and quality requirements.
• Develop, execute, and approve validation protocols, reports, and routine sterilization release documentation.
• Evaluate product and packaging characteristics to establish sterilization processing parameters and performance requirements.
• Implement and maintain sterilization process controls and microbiological monitoring programs.
• Support investigations, root cause analysis, and CAPA activities related to sterilization processes.
• Collaborate with global cross-functional teams to standardize sterilization strategies and best practices.
• Maintain sterilization risk assessments, including FMEAs, and support audit readiness activities.
• Provide technical support to manufacturing operations, including equipment qualification and calibration oversight.

Skills

Sterility Assurance

EO sterilization

Quality engineering

Regulatory compliance

English fluency

Education

Bachelor's degree

Master's degree (preferred)

Tools

Minitab

Job description

Medtronic Singapore Operations Pte Ltd in Singapore is seeking a Sterilization Engineer II to support EO sterilization validation, process control, and continuous improvement within Sterility Assurance. You will partner with manufacturing, quality, microbiology, packaging, and regulatory teams to ensure compliance and robust sterilization programs across the product lifecycle.

Based in Singapore with an onsite work arrangement, the role focuses on leading validation activities, developing