About the role

AI summarised

The Sterilization Engineer II at Medtronic is responsible for ensuring Ethylene Oxide (EO) sterilization processes comply with regulatory and quality standards (FDA, PMDA, ISO 11135, ISO 13485). The role involves leading validations, process improvements, and global standardization initiatives, as well as providing technical support and mentoring.

MedTechFull-timeGeneral

Key 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.

Requirements

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.
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.