Sterilization Engineer II

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 may include the following and other duties may be assigned. 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 de ... (truncated, view full listing at source)