Director Microbiologist - Sterilization (West Americas Platform) ID-9742
- Vision , Medical , Dental , Paid Time Off , Life Insurance , Retirement
- Full-Time
At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You'll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.
A Day in the LifeThe Director Microbiologist - Sterilization 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 facilities in the West Americas Platform. Reporting to the Vice President of Operations Quality for Americas West / Mexico Manufacturing Region.Based at a Medtronic Manufacturing site in Southern California (Irvine, Santa Ana or Northridge) you will have a Hybrid work schedule with Sterility Assurance responsibility for Manufacturing Facilities in California, Colorado, Arizona and Mexico. This position will require up to 35% travel annually to sites within the West Region (USA & Mexico). A current and valid Passport is required.
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. We strive without reserve to deliver quality results that create a competitive advantage and reinforce our position as an industry thought leader and a trusted partner.
As the Director Microbiologist - Sterilization, you will:
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Guide engineers and scientists on solving complex technical problems related to medical device microbiology and sterilization.
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Set direction and strategy for the Global Microbiological Quality and Sterility Assurance Team.
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Organize teams and deploy resources to effectively support operating units, manufacturing sites, and enterprise functions.
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Advise and inform Senior Leadership and Executives with respect to sterilization issues, provide and lead risk assessment and mitigation strategies, and collaborate with enterprise partners and suppliers to ensure business continuity.
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Facilitate "One Best Way" and the "Medtronic Mindset" within the microbiological quality and sterility assurance community.
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Partner cross-functionally with colleagues in Strategy & Technology, Supplier Quality, Global Operations & Supply Chain, Regulatory Affairs, R&D, and others.
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Develop talent and coach / mentor Managers, Engineers, and Scientists.
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Influence new approaches toward device design and development and manufacturing process design and controls.
Responsibilities and Expectations may include the following and other duties may be assigned.
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Must have the flexibility and technical agility to manage diverse teams across regional locations.
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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.
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Must have strong business and financial acumen.
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Experience in balancing the needs of operations and compliance opportunities.
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Strong communication skills with the ability to influence others without direct authority.
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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.
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Good communication and writing skills.
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Create 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.
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Define and maintain a strategy for sterility assurance effectiveness for the sites under the West Americas Regional Platform.
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Act as the regions SME for sterilization and microbiology.
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Must be comfortable dealing with strong management teams and able to positively influence when necessary.
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Professionally represent the company with key industry bodies and where required, government agencies (i.e., US FDA).
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Experience with validating and maintaining multiple site sterility assurance programs to include controlled environments, process water systems, and various sterilization modalities (EtO Ethylene Oxide, VHP, MH, Dry Heat, Radiation).
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Highly effective in a matrix organization with a track record of influencing others without having direct authority.
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Skilled at project management and executive communication skills.
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Emotionally intelligent and can balance multiple priorities in the face of challenges and constraints.
Must Have: Minimum Requirements
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Bachelor's degree and minimum of 10 years of relevant Microbiology - Sterilization experience within a Manufacturing Environment with 7+ years of managerial experience, or an advanced degree with a minimum of 8 years of relevant Microbiology - Sterilization experience within a Manufacturing Environment with 7+ years of managerial experience.
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Must maintain a current and valid Passport, with availability to travel up to 35% annually to sites within the West Region (USA & Mexico).
Nice to Have
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Degree in Engineering or Technical Sciences.
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Experience in a highly regulated industry, preferably medical device, with global manufacturing.
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AAMI Certification.
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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.
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Comfortable with presenting technical information on behalf of Medtronic to external conferences or other mediums.
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English-Spanish bilingual
Physical Job Requirements
The 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.
Benefits & CompensationMedtronic offers a competitive Salary and flexible Benefits Package
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.
This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).
This position is eligible for an annual long-term incentive plan.
The base salary range is applicable across the United States, excluding Puerto Rico. Base pay is based on numerous factors and may vary by job-related knowledge, skills, experience, etc. Compensation and benefits information pertains solely to candidates hired within the United States (local market compensation and benefits will apply for others).
The following benefits and additional compensation are available to those regular employees who work 20+ hours per week: Health, Dental and vision insurance,Health Savings Account,Healthcare Flexible Spending Account,Life insurance, Long-term disability leave,Dependent daycare spending account,Tuition assistance/reimbursement, andSimple Steps (global well-being program).
The following benefits and additional compensation are available to all regular employees:Incentive plans, 401(k) plan plus employer contribution and match,Short-term disability,Paid time off,Paid holidays,Employee Stock Purchase Plan,Employee Assistance Program,Non-qualified Retirement Plan Supplement (subject to IRS earning minimums), andCapital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums).
Regular employees are those who are not temporary, such as interns. Temporary employees are eligible for paid sick time, as required under applicable state law, and the Employee Stock Purchase Plan. Please note some of the above benefits may not apply to workers in Puerto Rico.
Further details are available at the link below:
Medtronic benefits and compensation plans
About Medtronic
We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.
Our Mission - to alleviate pain, restore health, and extend life - unites a global team of 95,000+ passionate people.
We are engineers at heart- putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.
Learn more about our business, mission, and our commitment to diversity here.
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.
If you are applying to perform work for Medtronic, Inc. ("Medtronic") in any position which will involve performing at least two (2) hours of work on average each week within the unincorporated areas of Los Angeles County, you can findhere a list of all material job duties of the specific job position which Medtronic reasonably believes that criminal history may have a direct, adverse and negative relationship potentially resulting in the withdrawal of a conditional offer of employment. Medtronic will consider for employment qualified job applicants with arrest or conviction records in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.
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