Senior Microbiologist-Sterilization Engineer

Medtronic • Fridley, MN

1d • $98,400 - $147,600 • Onsite

About The Position

Medtronic’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.

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.
• Possess unrestricted U.S. work authorization at the time of hire and for the duration of employment.

Nice To Haves

• 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.

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.

Benefits

• 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)

What This Job Offers

• Job Type: Full-time
• Career Level: Senior