Sterilization Engineer II

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

At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.

A Day in the Life The Sterilization Engineer II is responsible for ensuring that sterilization processes - particularly Ethylene Oxide (EO) - are compliant with regulatory and internal quality system requirements, including FDA, PMDA, ISO 11135, and ISO 13485 standards. S/He will lead sterilization validations, process improvements, and global standardization initiatives.

Responsibilities

• Ensure sterilization processes including sterilization release and validation complies with specifications and all relevant FDA regulations and ISO standards, such as ISO 11135, ISO 13485.
• Validate and implement sterilization processes and microbiological controls.
• Navigate within the QMS to create and release documents and procedures, including validation protocols/reports, routine release documentation, and procedural updates.
• Creates & executes validation documentation with full stakeholder alignment covering product scope, resistance hierarchy, process equivalency, performance qualifications, etc.
• Works with product/packaging stakeholders to evaluate product limitations & determine EO sterilization processing bounds.
• Collaborate with global teams to align strategy, planning and execution of sterilization processes, protocols, and best practices.
• Oversee the requalification, maintenance and calibration of sterilization equipment to ensure optimal performance.
• Provide technical support to manufacturing operations, including root cause analysis, CAPA implementation, and training.
• Drive and participate in continuous improvement initiatives related to sterilization effectiveness, efficiency, and compliance.
• Maintain and update sterilization-related risk assessments (e.g., FMEAs).
• Support or lead investigations and corrective/preventive actions (CAPAs) related to sterilization.
• Actively participate in internal and inter-facility audits to assess compliance and process robustness.
• Perform additional responsibilities or project assignments as directed by the Manager or Supervisor.

Attributes

• Demonstrates high ethical standards and integrity in all actions and decisions.
• Flexible and adaptable to changing priorities, challenges, and environments.
• Strong team player, including cross-functional teams, with a collaborative mindset.
• Meticulous attention to detail and commitment to quality.
• Provides technical guidance and mentorship to less experienced engineers.
• Excellent problem-solving skills.
• Proven project management and interpersonal skills.
• Excellent organizational and judgment skills.

Required Knowledge and Experience

• Bachelor’s degree in engineering (Microbiology, Biotechnology, etc.) or equivalent Advanced degree (e.g., Master’s) is a plus and may reduce experience requirements.
• Relevant certifications in sterilization or quality systems are advantageous.
• Minimum of 2 years of experience in medical device or pharmaceutical industry, preferably within Sterility Assurance; or a minimum of 0 years of relevant experience with an advanced degree (Master’s or higher).
• Experience and knowledge of applicable standards and regulations (e.g., ISO 11135, ISO 13485, FDA, PMDA).
• Direct experience with EO sterilization equipment, process controls & change management.
• Experience with parametric release processing.
• Knowledge in microbiological testing includes bioburden, endotoxin, EO residual testing and cleanroom control is advantageous.
• Proficiency in written and spoken English.
• Strong communication and interpersonal skills; able to clearly articulate technical concepts across all levels of the organization.
• Computer proficiency using word, spreadsheet, 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).

About Medtronic

We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions. Our Mission - to alleviate pain, restore health, and extend life - unites a global team of 95,000+ passionate people. We are engineers at heart - putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves.

We have the talent, diverse perspectives, and guts to engineer the extraordinary. Learn more about our business, mission, and our commitment to diversity here

Working alongside one another, we use science, medicine, and a profound understanding of the human body to build extraordinary technologies that can transform lives. We build extraordinary solutions as one team. With one Medtronic Mindset defining how we work.

Speed and decisiveness run through our DNA.

Diverse perspectives inspire our bold answers to any challenge that comes our way. And we deliver results the right way, breakthrough after patient breakthrough.

This life-changing career is yours to engineer. By bringing your ambitious ideas, unique perspective and contributions, you will… Build a better future, amplifying your impact on the causes that matter to you and the world Grow a career reflective of your passion and abilities Connect to a dynamic and inclusive culture that welcomes the challenge of life-long learning These commitments set our team apart from the rest: Experiences that put people first. Respect for people is the hallmark of our humanity. It fuels our team to positively impact even a single life. And it means we put our people first at Medtronic as well, creating a culture of belonging and always pushing to get you the career-building resources you need.

Life-transforming technologies. No matter your role, you contribute to technologies that transform lives. Better outcomes for our world. Here, it’s about more than the bottom line. Our Mission to improve human welfare drives us.

We advance healthcare, society, and equity with every design, inside and outside our walls. Insight-driven care. Fresh viewpoints. Cutting-edge AI, data, and automation.

You’re shaping the future of healthcare technology and defining the next generation of breakthroughs in care

Equal Employment Opportunity

It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.

For sales reps and other patient facing field employees, going into a healthcare setting is considered an essential function of the job and we expect our employees to comply with all credentialing requirements at the hospitals or clinics they support.

This employer participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees.

For further information about the E-Verify program.