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MEMedtronic logo

Medtronic

SGP-04 Changi III, Singapore

Sterilization Engineer II.

REMOTEMIDDLE LEVELENGINEERING
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.  ‌ ‌ Recruitment Fraud Alert We are aware of phishing scams targeting job seekers. Please keep the following in mind: Apply only through official Medtronic channels. All legitimate Medtronic recruiting communications come from approved Medtronic platforms and official @medtronic.com email addresses. Medtronic will never ask for payment or sensitive personal information (such as bank account or Social Security details) during early stages of the hiring process. Any such requests are not legitimate. If you receive a suspicious message claiming to be from Medtronic, do not respond, click links, or open attachments. If you have any questions, concerns regarding the authenticity of a communication alleged to have been made by or on behalf of Medtronic, please contact us immediately at [email protected]. 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). Thank you for visiting the career site dedicated to Medtronic employees recently impacted by a reduction in force (RIF). We encourage you to explore available job opportunities at Medtronic that match your qualifications and interests. Please note that when registering on this site, you will need to use an external email address. For former Medtronic employees and those seeking new external opportunities, we invite you to apply for career opportunities by visiting our external career site at MedtronicCareers. We look forward to supporting you in your career journey.
Pay
Not stated
Where
SGP-04 Changi III, Singapore
Work
Remote
Type
Not stated
Posted
12 Nov, 2026
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