At Medtronic you can begin a life-long career of exploration and innovation while helping champion healthcare access and equity for all. Youll lead with purpose breaking down barriers to innovation in a more connected compassionate world.

A Day in the Life

Act boldly. Compete to win. Move with speed and decisiveness. Foster belonging. Deliver resultsthe right way. Thats the Medtronic Mindset our cultural norms. Our brand is rooted in action not just words. The Medtronic Mindset defines the expectations of our culture. Every person here plays a role in bringing it to life. We recognize your extraordinary potential to ensure future generations live better healthier lives.

In this vital position as a Microbiology & Sterilization Manager you will lead a team of talented technicians scientists and engineers with responsibility for sterility assurance microbiology and environmental controls across several manufacturing sites in the Central Region. The Microbiology & Sterility Assurance team plays a key role in transforming the future of healthcare and fulfilling the Medtronic Mission to alleviate pain restore health and extend life. The incumbent will report through the Central Region Sterility Assurance Leader as part of the Global Operations and Supply Chain Quality organization.

Responsibilities may include the following and other duties may be assigned.

• Guide engineers and scientists who analyze chemical biological or microbiological products raw materials in-process materials release test samples or stability samples in support of the companys quality program.

• Oversee local / site-based laboratory activities such as preparation cleaning disinfection and/or sterilization of instruments materials products and/or supplies; qualitative tests or quantitative assays on samples using techniques that may range from use of traditional analytical instruments to highly modern and automated instrumentation.

• Measure and monitor KPIs for sites under their responsibility and report these to leadership.

• Write protocols and procedures describing how to clean sterilize and/or deliver sterile products supplies and/or instruments.

• Interpret and evaluate laboratory analyses for accuracy and precision; verify test results against specifications and recommend and implement corrective action where necessary.

• Develop and implement procedures and protocols for management of controlled environments.

• Ensure microbiological quality of medical devices and controlled environments at assigned sites; lead corrective and preventive action (CAPA) and continuous improvement activities.

• Identify and implement opportunities for improvement in microbiology and sterility assurance processes with respect to quality and efficiency.

• May also be involved in establishing microbiology and sterilization requirements for the transfer of new products and test methodology from R&D to manufacturing.

• Serve as the Subject Matter Expert (SME) for microbiology and sterility assurance at assigned sites and support audits and inspections both internal and external (regulatory and health authorities).

• Travel Required: Role requires 10% travel to multiple manufacturing sites in the Central Region.

Required Knowledge and Experience:

• Experience in balancing the needs of operations and compliance.

• Strong writing and communication skills with the ability to influence others without direct authority.

• An empathic and candid leader that understands the power of the collective team and builds strong relationships.

• Experience as an SME for sterilization and microbiology in audit situations.

• Must be comfortable dealing with strong management teams and able to positively influence when necessary.

• Professionally represent the company with key industry bodies and where required government agencies (i.e. US FDA Notified Bodies).

• Experience with validating and monitoring controlled environments process water systems and/or various sterilization modalities (Ethylene Oxide (EO) Vaporized Hydrogen Peroxide (VHP) Moist Heat Dry Heat and/or Radiation).

• Requires practical knowledge in leading and managing the execution of processes projects and tactics within medical device microbiology & sterilization.

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.

Must Have: Minimum Requirements

To be considered for this role please ensure the minimum requirements are evident in your applicant profile.

• Bachelors degree in science or technical field with 5 years of work experience in microbiology sterilization and/or biocompatibility experience OR Advanced Degree in Science or technical field with 3 years of work experience in microbiology sterilization and/or biocompatibility experience.

Nice to Have

• Degree in Engineering or Technical Sciences (Microbiology Chemistry Biology Biochemistry Materials Science etc.).

• Experience in a highly regulated industry preferably medical device with global manufacturing.

• AAMI Certification (CISS) or ASM Certification (NRM).

• An active participant in the development of industry standards impacting sterility assurance in pharma or medical devices as an active voting member of a working group; staying up to date with changing regulations and trends and actively sharing that knowledge with leadership.

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.

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.

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

About Medtronic

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 95000 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.

Learn more about our business mission and our commitment to diversity here.

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.