Sterilization Engineer II (Ethylene Oxide)

About the role

Medtronic is hiring a Sterilization Engineer II in Singapore, working onsite. The role sits in the Sterility Assurance function and supports the validation, control and continuous improvement of sterilization processes for medical devices. It focuses primarily on Ethylene Oxide (EO) sterilization and works with manufacturing, quality, microbiology, packaging and regulatory stakeholders to meet global regulatory and quality standards.

Key responsibilities

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

Required profile

• Bachelor's degree with 2+ years of experience in Sterility Assurance, sterilization engineering, quality engineering or related medical device or pharmaceutical manufacturing experience.
• Experience with EO sterilization, validation, process controls and change management.
• Knowledge of ISO 11135, ISO 13485, FDA requirements and other sterilization regulations.
• Experience writing and executing validation documentation and quality system records within a QMS.
• Fluent written and spoken English.

Preferred qualifications

• Master's degree in Engineering, Microbiology, Biotechnology or a related field.
• Parametric release processing experience.
• Knowledge of bioburden, endotoxin, EO residual and cleanroom monitoring testing.
• Certification in sterilization or quality systems.
• Statistical analysis tools such as Minitab.

What we offer

• Competitive salary and a flexible benefits package.
• Eligibility for the Medtronic Incentive Plan (MIP).