Associate Sterilization Specialist / Microbiologist
Careers that Change Lives
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.
A Day in the Life
The Associate Microbiologist / Sterilization Specialist will focus on sterilization and microbial compliance for medical devices at the Sterility Assurance East Manufacturing unit. The position will serve as a subject matter expert for Ethylene Oxide and Gamma Irradiation sterilization, as well as bioburden and endotoxin monitoring. The position will have a primary focus within the core team with the responsibilities including but not limited to cycle / product validation and requalification, environmental and microbial monitoring, product change assessments, procedural updates and maintenance, and operation of the in-house sterilization chamber. The position will also partner with engineering, manufacturing, plant quality, and other cross functional stakeholders to understand process feasibility, determine risks, identify challenges & create solutions.
Responsibilities may include the following and other duties may be assigned.
- Learn and establish testing protocols and procedure for requalification of sterilization cycles / products.
- Interpret and evaluate changes to product or process and assess their microbiological impact to sterilization.
- Navigate and manage controlled monitoring programs for microorganisms and clean room environments and execute investigations and corrective actions.
- Update and implement SOP procedures based on departmental needs and requirements.
- Perform product and process validations according to ISO guidelines and internal procedures.
- Manufacturing of validation materials for process qualifications and able to setup said validation approach according to an established protocol
- 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.
- Develop, validate, and implement controlled environment methods.
- Perform qualitative tests or quantitative assays on samples using techniques that vary from use of standard analytical equipment to highly modern and automated instrumentation.
Must Have: Minimum Requirements
- Bachelors degree required in Science or Technical Field
- 0 years of experience required
Nice to Have
- Bachelor's degree in science or technical field with 1 year of work experience in microbiology, sterilization, and/or biocompatibility experience
- Flexible and open minded in regard to daily task requirements and prioritizing of projects.
- Able to work collaboratively and efficiently in both a team environment and individually on specific projects.
- On site employment is preferred but willing to accommodate 1-2 days remote work a week.
- Familiarity with EtO and Gamma sterilization modalities as well as bioburden, endotoxin, and environmental monitoring of manufacturing clean rooms.
- Strong understanding of Microsoft apps (Excel, Word, etc.).
About Medtronic
Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be.
We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Let’s work together to address universal healthcare needs and improve patients’ lives. Help us shape the future.
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. Learn more about our benefits here.
The provided base salary range is used nationally in the United States (except in Puerto Rico and certain CA locations). The rate offered is compliant with federal/local regulations and may vary by experience, certification/education, market conditions, location, etc.
Physical Job Requirements
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. (ADA-United States of America)
