Sterilization Engineer II

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

Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first — developing innovative medical technologies that improve the lives of 72+ million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact.

A Day in the Life

This role is part of the Sterility Assurance function, supporting the validation, control, and continuous improvement of sterilization processes for medical devices. The team partners with manufacturing, quality, microbiology, packaging, and regulatory stakeholders to ensure sterilization systems comply with global regulatory and quality standards while supporting product safety and operational performance.

This position is based in Singapore and follows an onsite work arrangement.

The Sterilization Engineer II is responsible for supporting and advancing sterilization processes, with primary focus on Ethylene Oxide (EO) sterilization. The role leads validation activities, supports process improvements, ensures compliance with applicable regulations and standards, and collaborates with global stakeholders to maintain effective and robust sterilization programs across the product lifecycle.

Primary Responsibilities

• Lead sterilization validation and requalification activities for Ethylene Oxide (EO) processes in accordance with applicable 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 corrective and preventive action (CAPA) activities related to sterilization processes.
• Collaborate with global cross-functional teams to standardize sterilization strategies, protocols, and best practices.
• Maintain sterilization risk assessments, including Failure Mode and Effects Analyses (FMEAs), and support audit readiness activities.
• Provide technical support to manufacturing operations, including equipment qualification, calibration oversight, and process improvements.

Required Qualifications

• 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 Ethylene Oxide (EO) sterilization processes, validation, process controls, and change management.
• Knowledge of ISO 11135, ISO 13485, U.S. Food and Drug Administration (FDA) requirements, and other applicable sterilization regulations and standards.
• Experience authoring and executing validation documentation, technical reports, and quality system records within a Quality Management System (QMS).
• Fluency in written and spoken English.

Preferred Qualifications

• Master's degree in Engineering, Microbiology, Biotechnology, or a related technical discipline.
• Experience with parametric release processing.
• Knowledge of microbiological testing, including bioburden, endotoxin, EO residual, and cleanroom monitoring programs.
• Certification in sterilization, quality systems, or a related discipline.
• Experience using statistical and data analysis tools, including Minitab.

Physical Job Requirements

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.

Benefits & Compensation

Medtronic offers a competitive Salary and flexible Benefits Package

A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create.We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.

This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).