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Principal Microbiologist-Sterilization

📁
Research & Development
📅
200000J9 Requisition #
Careers That Change Lives
In this exciting role as a Principal Microbiologist-Sterilization for Cardiac Surgery you will be responsible for following policies and procedures to assure that Medtronic medical devices consistently comply with sterility assurance requirements, standards, guidelines and industry practices, both domestic and international.
 
CVG
The Cardiac and Vascular Group brings all of our cardiac and vascular businesses together into one cross-functional, collaborative operating unit to employ the full breadth of our talent, technologies, products, services, and solutions to address the needs of customers and patients across the globe.
 
CORONARY AND STRUCTURAL HEART provides interventional devices to treat coronary arteries that are blocked by atherosclerotic plaque and devices and therapies to treat structural defects of the heart.

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.

Interprets and evaluates test results in terms of accuracy and precision compared against established standards, procedures, and specifications. Recommends and implements corrective action where necessary.

Develops, validates, and implements sterilization, microbiological test, and 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.

Other Responsibilities:

Provides microbial technical expertise during new product development activities, process modification studies and failure investigations regarding microbiological contamination control.

Serves as technical liaison with functional groups, contract laboratories and manufacturing sites.

Assures compliance with all applicable international and domestic regulations and standards by defining policies and conducting regular training and assessments of all manufacturing sites.

Communicates detailed information regarding required policies and monitoring results to Manufacturing and Quality Assurance Managers.

Establishes trends; recommends revisions to monitoring program and/or manufacturing process controls. Ensures effective corrective actions are implemented, where necessary.

Provides microbiological technical expertise to aid in the sourcing, selection, and qualification of component vendors.

Defines handling and test requirements for microbiological contamination control of vendor-supplied components as well as work-in-process inventory.

Assure timely, accurate and independent evaluation of product performance and compliance to sterilization and microbiology requirements prior to clinical studies or market release.

Support other business units’ sterilization sites and microbiology labs, and act as an expert and advisor to drive improvements and changes.

Develop sterilization validation and sterility assurance control procedures, lead completion of testing and program requirements, document and interpret results.

Provides statistical support by leading creation of sterility assurance related metrics for improvement purposes.

Support Regulatory Affairs and other departments by providing reliability input in the evaluation of sterility assurance controls.

As part of the site Quality Operations team, this individual will also be cross trained in other site Quality Management System elements (CAPAs, Nonconforming Material Reports, etc.) and will support these activities on an as-needed basis.

 

 
Minimum Requirements:
Bachelor’s degree in Microbiology or similar scientific degree
7+ years of experience in medical device sterility assurance or related field, or 5+ years of experience with an advanced degree
 
Nice to Have
Knowledge in the application of international and national standards such as USP, AAMI/ANSI standards, ISO 22442 (Animal Origin), ISO 17665 (Steam), 11137 (Radiation), ISO 11737 (Microbial Method, ISO 14644 (Controlled Environments), ANSI/AAMI ST72 and others as applicable (i.e. EN).
Master’s degree in Microbiology or similar field
Certified microbiologist or toxicologist
7+ years industrial microbiology experience in the Medical Device or Pharmaceutical industry
Working knowledge of statistical techniques
 
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 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 Day in the Life 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.
Able to travel 10% or more as needed throughout calendar year.
 
EEO
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.
This employer participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here: http://www.uscis.gov/e-verify/employees

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