4 days left

Milwaukee County, Wisconsin, US
Jun 22, 2021
Jul 31, 2021
Project Management
Employment Type
Full time
Salary Type
Careers That Change Lives

In this exciting role as a Microbiologist you will have responsibility to support and improve the sterility assurance program for Medtronic Milwaukee, WI site. You will lead efforts that will focus on the current sterilization process, cleanroom technology, process water system and standardization. In this position, you will be responsible for validation/ revalidation activities related to sterilization processes, in addition to troubleshooting as needed for sterilization issues. This role will collaborate with other CST sites and Medtronic global sites to harmonize best practices for cleanroom and sterilization methodologies.


Cranial and Spinal Technologies (CST), an operating unit of Medtronic, shapes surgery for the better; delivering cranial, spinal, and orthopedic solutions. We are a leader in therapeutic biologics. We partner with other healthcare stakeholders to accelerate ground-breaking innovations that can improve surgical efficiencies and help create better outcomes for more patients.

The Cranial and Spinal Technologies operating unit brings all of our cranial and spinal technology businesses together into one cross-functional, collaborative group to employ the full breadth of our talent, technologies, products, services, and solutions to address the needs of customers and patients across the globe.

CORE SPINE AND BIOLOGICS offers treatment for degenerative spinal conditions, spinal deformity, herniated discs, spinal trauma and tumors, general/pediatric ventricular catheter placement, depth electrode/lead-probe placement, and cranial biopsies.

ENABLING TECHNOLOGIES offers surgical navigation systems, surgical imaging systems, powered surgical instruments, spine robotics, electrosurgical products, and interoperative nerve monitoring systems as support systems in the treatment of spine and cranial disease states.

CHINA ORTHOPEDICS provides economic value to healthcare providers through innovative products and solutions.

A Day in the Life

Responsibilities may include the following and other duties may be assigned.
  • Analyzes chemical, biological or microbiological products, raw materials, in-process materials, release test samples or stability samples in support of the company's quality program.
  • Prepares, cleans, disinfects, and/or sterilizes instruments, materials, products, and/or supplies.
  • Follows protocols and regulations in order to clean, store, and/or deliver products, supplies, and/or instruments.
  • Interprets and evaluates the analyses in terms of accuracy and precision compared against established specifications and recommends and implements corrective action where necessary.
  • Develops, validates, and implements controlled environment methods.
  • Applies existing techniques and procedures with recommendations and implementation of modification for improved efficiency, or devises and develops new analytical methods and techniques.
  • Performs 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.

Must Have: Minimum Requirements
  • Requires practical knowledge and demonstrated competence within job area typically obtained through advanced education combined with experience.
  • Requires a Bachelors degree and minimum of 2 years of relevant experience, or advanced degree with 0 years of experience

Nice to Have (Preferred Qualifications)
  • Work experience in microbiology, sterilization, and/or biocompatibility experience strongly recommended.
  • Hands on experience and knowledge of radiation sterilization (dose mapping, dose setting, dose audits, routine processing, sterilization validation, bioburden validation, microbial characterizations, and VDmax methodology).
  • Demonstrates understanding of the audit process including types of audits, planning, preparation, execution, reporting results, and follow-up.
  • Develops technical solutions to a wide range of difficult problems. Solutions are innovative and consistent with the organizations objectives and quality system requirements.
  • Familiar with ISO and guidance documents related to sterility assurance - sterilization (ISO 11137, ISO TIR 13004, AAMI TIR 39), microbiology (ISO 11737 series), cleanrooms (ISO 14644 series, ISO 14698, AAMI TIR 52), and quality systems (ISO 13485)
  • Act as a SME on sterility assurance and as a point-of-contact for regulatory audits.
  • Manages external standards pertaining to sterilization and microbiology for medical devices
  • Reviews sterilization deviations and provides technical support to assist with the release of sterilization loads and ensure compliance to procedures and regulatory requirements and ensure product quality issues are addressed
  • Possess a proactive-preventative mind set and actively pursues continuous improvements to ensure the continued success of the sterility assurance program.
  • Must be an effective team player intra-departmentally and cross functionally.
  • Leadership skills that include project management, training and presentation, and the ability to champion teamwork.
  • Ability to lead, develop, validate, implement, and defend business processes that impact sterilization.
  • Knowledge to execute and document investigations related to environmental and product bioburden non-conformances and equipment's out of tolerance in compliance with quality system requirements.
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.

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)

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