Mystic, Connecticut, United States
Aug 20, 2021
Careers That Change Lives
In this exciting role as a Senior Microbiologist you will have responsibility to support and improve the sterility assurance program for Medtronic Mystic site. You will lead efforts that will focus on the current sterilization process, cleanroom technology, process water system and laboratory compliance, 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 ENT sites and Medtronic global sites to harmonize best practices for cleanroom, laboratory operations, and sterilization methodologies.
The Ear, Nose, and Throat (ENT) operating unit of Medtronic is a global leader and trusted partner for innovative ENT solutions that improve patient access, outcomes, and customer satisfaction. We partner with the ENT community to understand the needs of customers and patients, delivering solutions that improve lives as we embody a culture of accountability and trust.
Over the past 20 years, ENT has become the global market leader in three key segments image-guided surgery, intraoperative nerve monitoring, and powered surgical instruments. ENT continues to launch valuable ENT solutions in these areas as well as tissue health and balloon sinus dilation.
Merocel is a product line that is part of the ENT product portfolio. Located in Mystic, CT, the facility manufacturers nasal dressings, epistaxis packing, sinus packing, ear packing and ear wicks for epistaxis, post-operative surgery and trauma.
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 companys 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
To be considered for this role, please ensure the minimum requirements are evident on your resume.
Bachelors Degree in Science or technical field with 4 years of work experience inmicrobiology, sterilization, and/or biocompatibility experience OR AdvancedDegree in Science or technical field with 2years of work experience inmicrobiology, sterilization, and/or biocompatibility experience.
Nice to Have (Preferred Qualifications)
- Hands on experience and deep knowledge of radiation sterilization (dose mapping, dose setting, dose audits, routine processing, sterilization validation, bioburden validation, microbial characterizations, VDmax methodology, and Method 1 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 equipments out of tolerance in compliance with quality system requirements.
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)
Travel can be up to 15 20%.
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.