1+ months

Sr Microbiologist-Steriliz

Santa Ana, CA 92702
  • Jobs Rated
Sr Microbiologist-Steriliz


Santa Ana, California, United States

Requisition #:


Post Date:

Dec 04, 2019

**Careers That Change Lives**

Provide support to Regulatory Affairs, Manufacturing, Product Development, and Special Engineering Projects. Make independent technical and functional decisions regarding acceptance or rejection of process, product components, subassemblies, solution, and the suitability of processes. Develop, monitor, and recommend manufacturing processes to ensure prevention of contamination and develop robust biological and microbiological monitoring and control system.

In this exciting role as a Sr. Microbiologist - Sterilization you will have responsibility to assure that products and processes are in control and in compliance with corporate, division, and regulatory requirements by the detection, appraisal, correction, and prevention of sterilization, contamination, and environmental control concerns. In addition, assure that all activities are in compliance with FDA, GMP/GLP, ISO 13485, MDD, and other national and international standards..


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**

Provide technical and biological evaluation and support to assigned operational areas (product development and/or manufacturing) including an objective microbial assessment.

Make appropriate recommendations and drive the implementation to improve the quality of lab activities including product and safety related issues.

Write, execute, review, and approve protocols and reports pertaining to microbiology, sterilization, and/or biocompatibility.

Provide objective microbial assessment through raw data review and trending.

**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 RD.

**Must Have: Minimum Requirements**

Bachelor's degree in Microbiology, 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

To be considered for this role, please ensure the minimum requirements are evident on your resume.

**Nice to Have**

Knowledge of International and national standards such as AAMI/ANSI standards, ISO 17665 (Steam Sterilization), 14160 (Liquid Chemical Sterilization), 11137 (Radiation Sterilization), 11135 (Ethylene Oxide Sterilization), and others as applicable (i.e. EN)

Knowledge of International standards in the use of materials of animal origin in medical device (ISO 22442).

Application of GLP regulations and ISO 10993 Biological Evaluation of Medical Devices

**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. Lets 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)

Less than 5% travel.
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.


Jobs Rated Reports for Biologist

Posted: 2019-12-06 Expires: 2020-02-13

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Sr Microbiologist-Steriliz

Santa Ana, CA 92702

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33rd2018 - Biologist
Overall Rating: 33/220
Median Salary: $62,290

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