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Senior Director, Microbiologist-Sterilization

2 months ago

Saint Paul, Minnesota, United States Medtronic Full time

Careers that Change Lives
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 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.

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.

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, recruiter or local HR to understand the Work Conditions and Physical requirements that may be specific to each role.

(ADA-United States of America)

A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create.

We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.

Learn more about our benefits here .

This position is eligible for a short-term incentive plan. Learn more about Medtronic Incentive Plan (MIP) here .

This position is eligible for an annual long-term incentive plan. Learn more about Medtronic Long-Term Incentive Plan (LTIP) here .

The provided base salary range is used nationally in the United States (except in Puerto Rico). Base pay is based on numerous factors and may vary depending on job-related knowledge, skills, experience, etc.

Min Salary

208400

Max Salary

312600


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.

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