Mid-level industry position
Location: Memphis, TN Help lead the effort to create global strategies for worldwide medical device approvals to introduce new products to market. In this exciting role as a Microbiologist–Sterilization Manager you will be a key member of Medtronic’s Sterilization Services Team. Impact patient outcomes. Come for a job, stay for a career. RTGThe Restorative Therapies Group develops life-restoring therapies and healthcare solutions that span the care continuum; integrating technologies and applying clinical and economic evidence to increase patient access, improve efficiency of procedures and deliver successful patient outcomes. Within RTG, the SPINE division shapes spine surgery for the better; delivering procedural solutions and therapeutic biologics and partnering with other healthcare stakeholders to accelerate innovations that can improve surgical efficiencies and help create better outcomes for more patients. As the Microbiologist–Sterilization Manager you will lead the Sterilization Services Team and work closely with cross-functional teams to manage and execute sterilization activities for new product introductions (NPI), Released Product Management (RPM) and sustaining sterilization projects. 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.
- Create proper work flow and manage/prioritize projects based on business needs.
- Provide technical solutions to research and development and manufacturing organizations using microbiological/sterilization theory and practice, i.e. Radiation, Ethylene Oxide and Steam Sterilization and Reprocessing Methodologies.
- Work with contract sterilizers to maintain sterilization validations using either Moist Heat, Radiation or Ethylene Oxide Sterilization in accordance with all industry, national and international guidance regulations.
- Interact with Regulatory, Quality, Packaging and R&D Engineering to maintain microbiological specifications and test plans necessary to ensure compliance with the overall Quality Requirements.
- Interact with Purchasing and Contract Sterilization/Test Facilities to ensure the Sterilization requirements and product testing procedures are clear, complete and understood.
- Knowledge in compendial (AAMI, USP, ISO) methodologies and techniques. Ability to read and interpret documents related to medical device sterilization and cleanrooms, including: national and international standards, regulations, technical procedures, journals, regulatory publications.
- Expertise in cGMP’s and quality systems as related to aseptically manufactured and terminally sterilized medical devices.
- Advanced knowledge of microbiology principles, methods and procedures, including knowledge of bacteria morphology and staining, aseptic technique specifically as they relate to sterilization methods.
- Environmental Monitoring (EM) and controlled environment subject matter expertise.
Must Have: Minimum Requirements
- Bachelor’s degree (e.g., Biological Science, Biomedical Engineering, Chemistry, Public Heath or related field) with a minimum of 5 years of experience leading/managing in sterilization or microbiology (e.g., clean room, sterilization/microbiology lab) or advanced degree with a minimum of 3 years of experience leading/managing in sterilization, or microbiology (e.g., clean room, sterilization/microbiology lab).
Nice to Have
- Experience at Medtronic or within a medical device industry.
- Experience in Quality.
- 2+ years of Program Management in sterilization, manufacturing operations or other relevant area.
- PMP certification; Project Management Certification (preferably PMI) and/or Green Belt Certification
- Proficient with MS Program, Excel, Word, PowerPoint, Project (or similar scheduling software), project management techniques and tools.
- Excellent project management skills, organization and communication skills.
About MedtronicTogether, 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 RequirementsThe 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 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)