Senior Microbiologist-Sterilization Engineer at Medtronic Fridley, MN

About the Position

Senior Microbiologist-Sterilization Engineer Job at Medtronic, Fridley, MN

Medtronic is a global leader in healthcare technology with a mission to alleviate pain, restore health, and extend life. We are seeking a Senior Microbiologist-Sterilization Engineer to join our Global Sterility Assurance (GSA) organization in Fridley, MN. This role will provide end-to-end microbiological quality and sterility assurance support across Medtronic's manufacturing network.

Responsibilities

• 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.

Requirements

• 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.

We Offer

• Competitive Salary and flexible Benefits Package
• Health, Dental and vision insurance
• Health Savings Account
• Healthcare Flexible Spending Account
• Life insurance
• Long-term disability leave
• Dependent daycare spending account
• Tuition assistance/reimbursement
• Simple Steps (global well-being program)
• Incentive plans
• 401(k) plan plus employer contribution and match
• Short-term disability
• Paid time off
• Paid holidays
• Employee Stock Purchase Plan
• Employee Assistance Program
• Non-qualified Retirement Plan Supplement (subject to IRS earning minimums)
• Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums)

About the Company

Medtronic is committed to fostering an environment where employees can thrive and make a meaningful impact. We offer equal employment opportunities to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law.

Apply Now

Interested candidates should apply through official Medtronic channels. For more information, visit our careers page.