Senior Microbiologist-Sterilization Engineer

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 95000 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.

Medtronics Global Sterility Assurance (GSA) organization provides end-to-end microbiological quality and sterility assurance support across Medtronics 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 -person exchanges are invaluable to our work. Were 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 degreeand minimum of 4 years of relevant experience OR Masters degree with a minimum of 2 years relevant experience OR PhD with 0 years relevant experience.

Nice to Have

• Bachelors 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 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 expertise aligns with long-term business needs. Roles below the Principal level require candidates to possess unrestricted U.S. work authorization at the time of hire and for the duration of employment.

Recruitment Fraud Alert

We are aware of phishing scams targeting job seekers. Please keep the following in mind:

Apply only through official Medtronic channels. All legitimate Medtronic recruiting communications come from approved Medtronic platforms and official @ email addresses.

Medtronic will never ask for payment or sensitive personal information (such as bank account or Social Security details) during early stages of the hiring process. Any such requests are not legitimate.

If you receive a suspicious message claiming to be from Medtronic do not respond click links or open attachments.

If you have any questions concerns regarding the authenticity of a communication alleged to have been made by or on behalf of Medtronic please contact us immediately at .

Medtronic offers a competitive Salary and flexible Benefits Package
A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits resources and competitive compensation plans designed to support you at every career and life stage.

Salary ranges for U.S (excl. PR) locations (USD):$98400.00 - $147600.00

This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).

The following benefits and additional compensation are available to those regular employees who work 20 hours per week: Health Dental and vision insuranceHealth Savings AccountHealthcare Flexible Spending AccountLife insurance Long-term disability leaveDependent daycare spending accountTuition assistance/reimbursement andSimple Steps (global well-being program).

The following benefits and additional compensation are available to all regular employees:Incentive plans 401(k) plan plus employer contribution and matchShort-term disabilityPaid time offPaid holidaysEmployee Stock Purchase PlanEmployee Assistance ProgramNon-qualified Retirement Plan Supplement (subject to IRS earning minimums) andCapital Accumulation Plan (available to Vice Presidents and above or subject to IRS earning minimums).

Regular employees are those who are not temporary such as interns. Temporary employees are eligible for paid sick time as required under applicable state law and the Employee Stock Purchase Plan. Please note some of the above benefits may not apply to workers in Puerto Rico.

Further details are available at the link below:

Medtronic benefits and compensation plans

It is the policy of Medtronic to provide equal employment opportunity (EEO) 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 addition Medtronic will provide reasonable accommodations for qualified individuals with disabilities.

If you are applying to perform work for Medtronic Inc. (Medtronic) in any position which will involve performing at least two (2) hours of work on average each week within the unincorporated areas of Los Angeles County you can findhere a list of all material job duties of the specific job position which Medtronic reasonably believes that criminal history may have a direct adverse and negative relationship potentially resulting in the withdrawal of a conditional offer of employment. Medtronic will consider for employment qualified job applicants with arrest or conviction records in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.