Full-timeHealthcare & care· Posted 14 Apr

Sterilization Engineer II

MedtronicFrom company site

Salary

Not stated by the company

When

Full-time hours

Where

Singapore

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Start: Not stated
Work mode: On-site
Experience: Some experience

About the role

This role sits within a global healthcare technology company and focuses on sterilization assurance, especially Ethylene Oxide (EO) processes. You will lead validations, process improvements and global standardization work while making sure everything meets regulatory and internal quality requirements. It suits an engineer with medical device or pharmaceutical experience who is meticulous, collaborative and comfortable working across teams.

What you'll do

Ensure sterilization processes, including release and validation, meet specifications and relevant FDA and ISO standards such as ISO 11135 and ISO 13485.
Validate and implement sterilization processes and microbiological controls.
Create and release QMS documents and procedures, including validation protocols and reports, routine release documentation and procedural updates.

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Develop and execute validation documentation with stakeholder alignment covering product scope, resistance hierarchy, process equivalency and performance qualifications.

Work with product and packaging stakeholders to assess product limitations and set EO sterilization processing bounds.

Collaborate with global teams on strategy, planning and execution of sterilization processes, protocols and best practices.

Oversee requalification, maintenance and calibration of sterilization equipment.

Provide technical support to manufacturing operations, including root cause analysis, CAPA implementation and training.

Drive and take part in continuous improvement initiatives for sterilization effectiveness, efficiency and compliance.

Maintain and update sterilization risk assessments such as FMEAs.

Support or lead investigations and corrective/preventive actions related to sterilization.

Take part 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.

Good to know

This is a full-time position based in Singapore.
The role is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).
The company offers a competitive salary and flexible benefits package.

Requirements

Bachelor's degree in engineering (e.g. Microbiology, Biotechnology) or equivalent
At least 2 years of experience in the medical device or pharmaceutical industry, preferably in sterility assurance; or 0 years with an advanced degree (Master's or higher)
Knowledge of applicable standards and regulations such as ISO 11135, ISO 13485, FDA and PMDA
Direct experience with EO sterilization equipment, process controls and change management
Experience with parametric release processing
Proficiency in written and spoken English with strong communication and interpersonal skills

Benefits

Competitive salary
Flexible benefits package
Eligible for the Medtronic Incentive Plan (MIP), a short-term incentive

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Medtronic

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Sterilization Engineer II

About the role

What you'll do

Good to know

Requirements

Benefits

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