Medtronic
Senior Microbiologist - Sterilization (Finance)
A Day in the Life
This position will support the Sterility Assurance/Microbiology program at the Boulder, Colorado site. This role will be working closely with a cross-functional group including Manufacturing, Quality, R&D, and Regulatory Affairs in order to validate and maintain sterilization processes that include a majority of ethylene oxide, and some radiation, and device reprocessing. Additional responsibilities will include product/process change evaluations and their impact to existing sterilization methods, and supporting internal/external audits as the site's SME for sterility assurance.
Senior Microbiologist-Sterilization, Boulder Colorado
LOCATION: Must sit onsite in Boulder
Careers that Change Lives
The Senior Microbiologist- Sterilization position will be responsible for the medical device sterilization program and biocontamination control of the Boulder, Colorado cleanrooms. As the site's subject matter expert, the Sr. Microbiologist will play a critical role in ensuring that product is manufactured in a microbially controlled environment and that it meets our required sterility assurance levels. The Sr. Microbiologist must work independently and within of a variety of local and international teams to achieve these goals.
A Day in the Life
POSITION RESPONSIBILITIES MAY INCLUDE THE FOLLOWING AND OTHER DUTIES MAY BE ASSIGNED:
• Responsible for new product sterilization validations utilizing ethylene oxide, radiation, and other modalities.
• Responsible for demonstrating the continued effectiveness of commercial product sterilization processes including annual reviews, periodic requalifications, and product dose audits.
• Responsible for assessing and documenting the sterilization impact of sterilization processing deviations and product changes onsite and at our suppliers.
• Coordinates any needed sterilization or microbiological testing needed in compliance with ISO, EN, and USP with our contract sterilization facilities and test laboratories.
• May work with internal Regulatory Affairs group drafting device submissions and responding to regulatory inquiries.
• Will act as the site SME for all sterilization and controlled environment questions when supporting onsite and remote external audits by FDA, Notified Bodies, other regulatory agencies as well as internal audits.
• May travel to other Medtronic sites, contract sterilizers and laboratories to support performing audits of their sterilization and microbiological programs.
• Responsible for evaluation of OOS investigations into controlled environment microbial and particulate monitoring. Will work with cross-functional teams to determine product impact, required environmental testing and root-cause investigations.
• Responsible for reviewing changes to controlled environments and performing risk assessments to determine if changes warrant adjustments to routine sampling program.
• All other duties as assigned.
Must Have: Minimum Requirements
Nice to Have
• Expertise in Ethylene Oxide and Radiation based sterilization modalities.
• Competence using a variety of computer software applications.
• Strong working knowledge of ISO 11135, 11137-1, 11137-2, 11138-1, 11138-2, 11737-1, 11737-2, 11737-3, 13485, 14644 series, 14698-1, 14698-2, 17025, EN 17141, and AAMI ST72.
• Experience operating within quality system requirements applicable to the medical device industry.
• AAMI CISS certification in EO and/or Radiation
• Strong problem solving and analytical skills
• Strong problem solving and analytical skills
• Excellent written communication skills
• Able to function independently as well as in a team environment
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.
Salary ranges for U.S (excl. PR) locations (USD):$95,200.00 - $142,800.00
This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).
The base salary range is applicable across the United States, excluding Puerto Rico and specific locations in California. The offered rate complies with federal and local regulations and may vary based on factors such as experience, certification/education, market conditions, and location. Compensation and benefits information pertains solely to candidates hired within the United States (local market compensation and benefits will apply for others).
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 90,000+ 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.
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 law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.
At Medtronic, most positions are posted on our career site for 3-7 days.