Senior Microbiologist-Sterilization Engineer

Medtronic; Plymouth (MN); On-site; USD 98,000 - 148,000; Full time

Job summary

Medtronic’s Global Sterility Assurance (GSA) organization leads end-to-end microbiological quality and sterility activities for medical devices. This onsite role supports Central Region sites, collaborating across QA, Operations, and manufacturing to ensure compliant, safe products.

The role emphasizes EO/radiation sterilization validation, process monitoring, and CAPA-driven improvements, with in-person collaboration at a minimum of four days onsite weekly.

Qualifications

• 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.
• Experience with sterilization validation/qualification and QA systems is preferred.
• Knowledge of FDA/ISO standards and electronic quality/document systems is advantageous.

Responsibilities

• Lead and execute microbiology and sterility activities for terminally sterilized devices, including EO and radiation validations.
• Provide SME for controlled environments, environmental monitoring, and bioburden testing.
• Review investigations, CAPAs, and risk assessments; apply root-cause analysis and verify corrective actions.
• Analyze microbiology data trends; prepare quality metrics and management reviews.
• Collaborate with Quality, Operations, Facilities, and suppliers to ensure product release and compliance.

Skills

Risk-based problem solving

Analytical thinking

Ability to lead cross-functional teams

Education

Baccalaureate degree

Master's degree

PhD

Tools

Excel

Power BI

Minitab

Job description

Onsite

Fridley, Minnesota, United States of America

Plymouth, Minnesota, United States of America

Full time

R78104

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 Life

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.

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 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.

Benefits & Compensation

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):$98,400.00 - $147,600.00

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 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 (https://www3.benefitsolver.com/benefits/BenefitSolverView?page_name=signon&co_num=30601&co_affid=medtronic)

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 (https://www.medtronic.com/content/dam/medtronic‑wide/public/united‑states/employee‑support‑services/careers/la‑county‑legal‑notice.pdf) 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.

We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.

Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people.

We are engineers at heart— putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.

We change lives . Each team member, each day, helps to improve and redefine how the world treats the most pressing health conditions, from heart disease to diabetes. Our industry leadership comes from the passion and ingenuity of our people. That’s who we are. Working alongside one another, we use science, medicine, and a profound understanding of the human body to build extraordinary technologies that can transform lives.

We build extraordinary solutions as one team . With one Medtronic Mindset defining how we work. Speed and decisiveness run through our DNA. Diverse perspectives inspire our bold answers to any challenge that comes our way. And we deliver results the right way, breakthrough after patient breakthrough.

This life-changing career is yours to engineer . By bringing your ambitious ideas, unique perspective and contributions, you will…

• Build a better future, amplifying your impact on the causes that matter to you and the world
• Grow a career reflective of your passion and abilities
• Connect to a dynamic and inclusive culture that welcomes the challenge of life‑long learning

These commitments set our team apart from the rest:

Experiences that put people first . Respect for people is the hallmark of our humanity. It fuels our team to positively impact even a single life. And it means we put our people first at Medtronic as well, creating a culture of belonging and always pushing to get you the career‑building resources you need.

Life-transforming technologies . No matter your role, you contribute to technologies that transform lives. What we build empowers patients to live life on their terms.

Better outcomes for our world . Here, it’s about more than the bottom line. Our Mission to improve human welfare drives us. We advance healthcare, society, and equity with every design, inside and outside our walls.

Insight-driven care . Fresh viewpoints. Cutting‑edge AI, data, and automation. You’re shaping the future of healthcare technology and defining the next generation of breakthroughs in care

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.

For sales reps and other patient facing field employees, going into a healthcare settingis considered an essential function of the job and we expect our employees to comply with all credentialing requirements at the hospitals or clinics they support.

This employer participates in the federal E‑Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E‑Verify program, please click here (https://www.e‑verify.gov/employees) .

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