Principal Sterilization Engineer – Ethylene Oxide

Medtronic is a leader in global healthcare technology, dedicated to alleviating pain, restoring health, and extending life. The Principal Sterilization Engineer will serve as a subject matter expert for ethylene oxide sterilization, focusing on validating processes and collaborating with cross-functional teams to enhance sterilization initiatives. This role requires technical expertise in sterilization processes and involves managing large projects with limited oversight while ensuring compliance and regulatory support.

Responsibilities:

• Serves as subject matter expert (SME) for EO sterilization initiatives
• Serves as lead SME within the core team developing, validating & implementing new EO sterilization processes
• Provides technical expertise in the characterization, development/definition, and validation of EO sterilization equipment & processes
• Manages large projects or processes with limited oversight from manager
• Navigate within the QMS to document validation activity
• Creates & executes validation documentation with full stakeholder alignment covering product scope, resistance hierarchy, process equivalency, performance qualifications, etc
• Ensures compliance and regulatory support provided for all validation activities completed
• Identifies adequate process monitoring specifications, including parametric release establishment
• Works with product/packaging stakeholders to evaluate product limitations & determine EO sterilization processing bounds
• Interprets and evaluates data to drive action
• Interfaces with manufacturing organization & respective stakeholders to validate, implement & handoff sterilization processes
• Provides technical support to the product design teams and manufacturing sites
• Provides feedback and recommendations to management on sterilization initiative performance, goals, and status
• Develops solutions to moderately complex problems, and/or makes moderate to significant improvements of processes, systems or products independently to enhance performance of job area
• Implements solutions to problems
• Reviews quality data and assesses sterilization and microbiological quality
• Travel up to 25% in support of initiatives

Requirements:

• Bachelor's Degree and 7+ years of Sterilization experience OR Master's Degree and 5+ years of experience OR PhD and 3+ years of experience
• Degree in Engineering, Microbiology or related technical discipline
• Ethylene Oxide (EO) Sterilization experience
• Degree in Engineering, Microbiology or related field
• Familiarity with FDA, EU and other international regulations, standards and guidelines governing sterilization of medical devices
• Experience developing, validating & implementing sterilization processes
• Experience conducting comparative resistance studies, load configuration assessments, coordinating with laboratory testing and authoring validation documentation
• Experience with sterilization parametric release processing
• Experience analyzing sterilization documentation, monitoring data & batch records
• General understanding of sterilization equipment, control systems and cycle programming / definition
• Leadership skills, managing major / moderately complex projects, including delegation of work and review of work products, at times acting as a team leader
• Experience and knowledge of ISO 11135 & referenced standards
• Experience in the Medical Device or Pharmaceutical industry
• Experience developing EO sterilization processes & parametric monitoring specifications
• Ability to work in a team environment, including cross-functional teams, and exert influence while maintaining a cohesive team
• Ability to apply advanced scientific principles and statistical techniques