Careers that Change LivesA Day in the Life
Provide support to Manufacturing, Regulatory affairs, Product Development, and Special Engineering Projects. Communicate and make 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 Microbiologist II 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. 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.
Responsibilities may include the following and other duties may be assigned.
- 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
- Review the microbiology test results, logbooks, report and other related documents.
• 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
Nice to Have
- Bachelors degree required
- Minimum of 2 years of relevant experience, or advanced degree with 0 years of experience
- 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
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)