Microbiologist Sterilization Specialist II

We anticipate the application window for this opening will close on - 12 Jun 2026 At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll 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 results…the right way. That’s 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.The Grand Rapids site, which manufactures cardiac surgery devices distributed worldwide, is seeking a Microbiologist-Sterilization Specialist to support sustained compliance and continuous improvement initiatives, playing a critical role in ensuring site microbiology and sterilization operations meet regulatory and quality expectations. Join a team of passionate microbiologists who each play a critical role in ensuring the parts we manufacture are safe and compliant.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.Understand and implement policies that ensure compliance for controlled environments on-site in accordance with ISO 14644 series.Follow protocols and regulations in order to clean, store, and/or deliver products, supplies, and/or instruments.Interpret and evaluate the analyses in terms of accuracy and precision compared against established specifications and recommends and implements corrective action where necessary.Perform review of microbiology laboratory tests and ensure product families are appropriately tested at set frequencies.Support internal microbiology lab as needed with analyzing chemical, biological or microbiological products, raw materials, in-process materials, release test samples or stability samples in support of the company's quality program.Develop, validate, and implement controlled environment methods and overall site contamination control.Apply existing techniques and procedures with recommendations and implementation of modification for improved efficiency, or devise and develop new analytical methods and techniques.Perform qualitative tests or quantitative assays on samples using techniques that vary from use of standard analytical equipment to highly modern and automated instrumentation.May also be involved in establishing requirements for the transfer of methodology from R&D projects.Prepare for internal and external audits and ensure manufacturing areas are compliant with internal work instructions. This includes performing quality walks and periodic assessment of internal processes.Perform corrective and preventative actions to support manufacturing nonconformances and close gaps from audits.Prepare, clean, disinfect, and/or sterilize instruments, materials, products, and/or supplies.Support change control of internal work instructions and policies to align with industry best practices.Must Have: Minimum Requirements To be considered for this role, please ensure the minimum requirements are evident in your applicant profile. Bachelor’s degree in science or technical field with 2+ years of work experience in microbiology, sterilization, and/or biocompatibility experience OR Advanced degree in science or technical field with 0+ years of work experience in microbiology, sterilization, and/or biocompatibility experienceNice to Have Experience in a cleanroom environment, preferably in medical device, pharmaceutical, or biotech manufacturing.Knowledge of cleanroom classifications (ISO Class 7–8) and contamination control practices.Experience with Environmental Monitoring of controlled environmentsWorking knowledge of trending data software (Minitab, Excel, etc.) and performing statistical analysisExperience with BET testingExperience writing cleanroom and other validation protocols and reportsExperience writing cleanroom, microbiology, or other deviation investigationsExperience with writing CAPA plans and effectiveness checksGeneral understanding working with EO sterilizationCISS certification, AAMI WG, or other external body training certificationsFlexible and open minded regarding daily task requirements and prioritizing projectsAble to work collaboratively and efficiently in both a team environment and individually on specific projectsStrong understanding of Microsoft apps (Excel, Word, etc.)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 RequirementsThe 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 Wor