Senior Microbiologist-Sterilization Engineer

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.

• 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.

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.

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 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.

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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 @medtronic.com 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 AskHR@medtronic.com. 

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The following benefits and additional compensation are available to those regular employees who work 20+ hours per week: 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, and Simple 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 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), and Capital 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 law. In 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 find here 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.