EO Sterilization Engineer II: Validation & Compliance Lead

MSO Medtronic Singapore Operations; Singapore; On-site; SGD 80,000 - 120,000; Full time

Job summary

Medtronic Singapore is seeking a Sterilization Engineer II to lead EO sterilization validations and ensure compliance with FDA and ISO standards. You will manage validation protocols, participate in cross-functional teams, and drive continuous improvement in sterilization processes.

The role requires a strong background in engineering with microbiology knowledge, experience in sterilization, and collaboration across global teams to maintain quality and regulatory readiness.

Qualifications

• Bachelor’s degree in engineering (Microbiology, Biotechnology, etc.) or equivalent; advanced degree a plus.
• Certifications in sterilization or quality systems are advantageous.
• Minimum of 2 years in medical device/pharma, preferably Sterility Assurance, or 0 years with master’s or higher.
• Experience with ISO 11135, ISO 13485, FDA, PMDA regulations.
• Direct EO sterilization equipment experience and change management knowledge.
• Knowledge of microbiological testing and cleanroom controls is a plus.

Responsibilities

• Ensure EO sterilization processes compliance with FDA/ISO standards.
• Lead sterilization validations and process improvements.
• Create and release validation protocols/reports and SOPs.
• Collaborate with global teams to align strategies and best practices.
• Oversee maintenance/calibration of sterilization equipment.
• Provide technical support to manufacturing including CAPAs.

Skills

EO sterilization

Regulatory standards

Quality systems

Microbiology knowledge

English proficiency

Process validation

CAPA handling

GxP compliance

Education

Engineering degree

Tools

Sterilization equipment

Job description

Medtronic Singapore is seeking a Sterilization Engineer II to lead EO sterilization validations and ensure compliance with FDA and ISO standards. You will manage validation protocols, participate in cross-functional teams, and drive continuous improvement in sterilization processes.

The role requires a strong background in engineering with microbiology knowledge, experience in sterilization, and collaboration across global teams to maintain quality and regulatory readiness.