Senior Microbiologist-Sterilization Engineer

Job description

We anticipate the application window for this opening will close on - 10 Oct 2026 Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first — developing innovative medical technologies that improve the lives of 72+ million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact. A Day in the LifeMedtronic’s Global Sterility Assurance (GSA) organization provides end-to-end microbiological quality and sterility assurance support across Medtronic’s manufacturing network. The organization provides governance and subject-matter expertise for microbiology, controlled environments and contamination control, product bioburden and bacterial endotoxin, sterilization process validation and maintenance, sterile release, quality-system compliance, risk management, and support for new-product development and manufacturing transfers. As a member of this team, you will support manufacturing sites in the Central Region, developing strong partnerships with functional groups across numerous OUs and throughout all stages of the device lifecycle. At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. In-person exchanges are invaluable to our work. We’re working a minimum of 4 days a week onsite as part of our commitment to fostering a culture of professional growth and cross-functional collaboration as we work together to engineer the extraordinary. Responsibilities may include the following and other duties may be assigned: Lead and execute microbiology and sterility assurance activities for terminally sterilized medical devices, including ethylene oxide and radiation sterilization validations, qualification and requalification, routine process monitoring, and technical reviews. Provide subject-matter expertise for controlled environments and contamination control, including cleanroom qualification, environmental and utility monitoring, product bioburden, bacterial endotoxin, particulate, sterility, and ethylene oxide residual testing. Initiate, support, and technically review Microbiology Investigation Reports, nonconformance reports, issue triage records, and CAPAs; apply risk-based problem solving to determine root or presumptive causes, assess product impact, define containment and corrective actions, and verify effectiveness. Analyze and trend microbiology and sterilization data over appropriate timeframes; prepare periodic reviews, quality metrics, and Tier or management-review content; identify emerging adverse patterns and recommend timely escalation or improvement actions. Assess changes to products, materials, suppliers, manufacturing processes, packaging or pallet configurations, facilities, utilities, equipment, and controlled environments for impact to sterility assurance, microbiological quality, endotoxin control, and validated process status. Develop, revise, and maintain protocols, reports, risk assessments, procedures, work instructions, and technical justifications in alignment with applicable regulations, international standards, internal quality-system requirements, and good documentation practices. Partner across Quality, Operations, Manufacturing Engineering, Facilities, laboratories, suppliers, contract sterilizers, and product-development teams to resolve quality events, support production and product release decisions, execute new-product or transfer activities, and deliver cross-site compliance initiatives. Support internal and external audits, regulatory inspections, and formal responses; maintain inspection readiness, communicate significant risks through Tier governance, and drive standardization and continuous improvement across site and regional Microbiology and Sterility Assurance processes.. Must Have: Minimum Requirements To be considered for this role, please ensure the minimum requirements are evident in your applicant profile. Requires a Baccalaureate degree and minimum of 4 years of relevant experience OR Master's degree with a minimum of 2 years relevant experience OR PhD with 0 years relevant experience. Nice to Have Bachelor’s or advanced degree in microbiology, biological sciences, biomedical engineering, chemical engineering, or a related technical discipline. Experience in the medical device, pharmaceutical, biotechnology, or other highly regulated industry, with demonstrated application of cGMP and quality-system requirements. Hands-on experience with industrial ethylene oxide and/or radiation sterilization, including validation, qualification, requalification, routine control, dose audits, cycle changes, product adoption, or assessment of sterilization deviations. Demonstrated expertise in one or more of the following: controlled environments and contamination control; environmental or utility monitoring; product bioburden; bacterial endotoxin testing; sterility testing; or microbiological product-impact assessment. Working knowledge of applicable FDA requirements and international standards, such as ISO 13485, ISO 11135, ISO 11137, ISO 11737, ISO 14644, ISO 14698, ISO 17664, ISO 17665, and relevant AAMI or USP guidance. Experience leading or supporting microbiology or sterilization investigations, NCMRs, CAPAs, issue triage, root-cause analysis, risk assessments, and effectiveness verification using evidence-based problem-solving methods. Ability to analyze and trend complex data, identify adverse patterns, translate findings into risk-based actions, and communicate conclusions through technical reports, dashboards, or management and Tier reviews; advanced Excel, Power BI, Minitab, or comparable analytical-tool experience is preferred. Experience authoring and reviewing validation protocols and reports, periodic reviews, procedures, work instructions, regulatory responses, and inspection-ready technical documentation in an electronic quality or document-management system. Demonstrated ability to prioritize multiple compliance and business-critical deliverables, work independently, influence cross-functional teams, and coordinate work across sites, laboratories, suppliers, and contract sterilization partners. Certified Industrial Sterilization Specialist or other relevant AAMI, ASQ, Lean, or problem-solving certification is preferred. For Baccalaureate degrees earned outside of the United States, a degree that satisfies the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A) is required. 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. The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. U.S. Work Authorization & Sponsorship At Medtronic, we are committed to fostering an environment where employees can thrive and make a meaningful impact. In alignment with our enterprise-wide workforce planning approach, U.S. work authorization sponsorship (H-1B, TN, J, etc.) is offered exclusively for Principal-level roles and above, where specialized expe