Senior Director, Microbiologist-Sterilization (Remote Option)

A career at Medtronic is like no other. We’re purposeful.

We’re committed. And we’re driven by our Mission to alleviate pain, retore health, and extend life for millions of people worldwide. We value what makes you unique.

Be a part of a company that thinks differently to solve problems, make progress, and deliver meaningful innovations. The Senior Director, Sterility Assurance will be responsible for all strategy, safety, quality, compliance, and execution of critical activities to ensure sterilization processes, controlled environments, and biocontamination controls are maintained for Medtronic’s Manufacturing East, Caribbean, and Central. These regions include the following sites – Caribbean – San Isidro, Dominican Republic; Ponce, Puerto Rico; Villalba, Puerto Rico; Humacao, Puerto Rico; Warsaw, Indiana; Alajuela, Costa Rica; Ribeirao Preto, Brazil; and Sao Sebastiao, Brazil.

Central – Brooklyn Center, Plymouth Nathan Lane, Tempe, Grand Rapids, Fort Worth, Milwaukee, Memphis, Bedford, Billerica, and Twin Cities campus East – North Haven, Danvers, Montreal, Eatontown, Mystic, and Jacksonville. 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.

Must Have: Minimum Requirements Requires a Baccalaureate degree and minimum of 15 years of industrial sterilization experience with 10 years of managerial experience, or advanced degree with a minimum of 13 years prior industrial sterllization experience, with a minimum of 10 years of managerial experience. Must be able to travel to sites at a minimum 20% - 30% within a calendar year.

Hands on experience with risk management programs that are centered on the mitigation of biocontamination control in controlled environments and design controls for sterilization in the development of new products. Nice to Have A current certified sterilization specialist designation with AAMI in at least one modality. An active participant in the development of industry standards impacting sterility assurance in pharma or medical devices as an active voting member of a working group; staying up to date with changing regulations and trends and actively sharing that knowledge with leadership.

Role Expectations: Good communication and writing skills in English. Must have the flexibility and technical agility to manage diverse teams across regional locations.

Must have strong business and financial acumen. Experience in balancing the needs of operations and compliance opportunities. Strong communication skills with the ability to influence others without direct authority.

An empathic and candid leader that understands the power of the collective team, builds strong relationships across a matrixed organization, with a track record of achieving wins across the enterprise. Creates an environment in which team members feel a strong sense of ownership and accountability; foster belonging for the team to share candidly to promote meaningful change. Mentor, coach, and develop existing site-based sterility assurance leads and identify talent (external/internal) into the function.

Define and maintain a strategy for sterility assurance effectiveness for the sites under the regional platform assigned. Act as the regions SME for sterilization and microbiology; providing SME support to sites undertaking business critical investigations (i.e., dose audit failures, endotoxin product failures); strong mathematical skills to calculate SAL to determine field impact. Actively participate in and promote the global sterility assurance community of practice/forum; using the community to align and standardize sterilization and biocontamination control best practices.

Must be comfortable dealing with strong management teams and able to positively influence when necessary. Able to professionally represent the company with key industry bodies and where required, government agencies (i.e., US FDA). Experience with the validation of end-user reprocessing instructions for reusable devices (cleaning, disinfection, and sterilization of reusable devices). Experience with validating and maintaining multiple site sterility assurance programs to include controlled environments, process water systems, and various sterilization modalities (EO, VHP, MH, Dry Heat, Radiation) Highly effective in a matrix organization with a track record of influencing others without having direct authority. Skilled at project management and executive communication skills.

Emotionally intelligent and can balance multiple priorities in the face of challenges and constraints. 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.