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A leading healthcare company is seeking a talented individual to contribute to their technical functions through microbiological analysis and sterilization processes at their Juarez Plant. Candidates should have a Bachelor's degree in a relevant field and at least 3 years of experience in the medical industry. This role involves analyzing samples, developing testing methods, and ensuring compliance with strict quality and environmental standards.
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 LifeResponsibilities may include the following and other duties may be assigned.
Directs and implements environmental control, sterilization validations, activities at the Juarez Plant. Engineers the management of controlled environment room systems and medical product sterilization processes.
Validation, coordination, and implementation of sterilization methods applicable to sterile products. • Validation, maintenance, and implementation of equipment and testing methods used in monitoring environmental contamination controls. • Continuous review and maintenance of specific documents related to controlled environment manufacturing rooms, including the control plan (FMEA), materials used, and pest control, environmental controls , sterilization process, sterilization regulations. • Review and analysis of environmental control monitoring trends, limits, sterilization deficiencies, and submissions. • Respond to NCRs and CAPAs related to environmental control and sterilization and follow up on them until effective closure. • Submit and follow up on observations and the status of environmental control and sterilization deliverables at related meetings. • Development and quality control of microbiological testing methods and controls. • Inventory control of materials used in environmental control monitoring and sterilization testing. • Reviews product transfers in accordance with sterilization and environmental control requirements.
TECHNICAL SPECIALIST CAREER STREAM:An individual contributor with responsibility in our technical functions to advance existing technology or introduce new technology and therapies. Formulates, delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering R&D, systems or initiatives related to new technologies or therapies – from design to implementation - while adhering to policies, using specialized knowledge and skills.
DIFFERENTIATING FACTORS
Autonomy:Established and productive individual contributor.
Works independently with general supervision on larger, moderately complex projects / assignments.
Organizational Impact:Sets objectives for own job area to meet the objectives of projects and assignments.
Contributes to the completion of project milestones.
May have some involvement in cross functional assignments.
Innovation and Complexity:Problems and issues faced are general, and may require understanding of broader set of issues or other job areas but typically are not complex.
Makes adjustments or recommends enhancements in systems and processes to solve problems or improve effectiveness of job area.
Communication and Influence:Communicates primarily and frequently with internal contacts.
External interactions are less complex or problem solving in nature.
Contacts others to share information, status, needs and issues in order to inform, gain input, and support decision-making.
Leadership and Talent Management:May provide guidance and assistance to entry level professionals and / or employee in Support Career Stream.
Required Knowledge and Experience:Requires practical knowledge and demonstrated competence within job area typically obtained through advanced education combined with experience.
Requires a Baccalaureate degree (or for degrees earned outside of the United States, a degree which satisfies the requirements of 8 C.F.R. § 214.2(h)( 4)(iii)(A) and minimum of 2 years of relevant experience, or advanced degree with 0 years of experience.
Bachelor's degree in Chemistry, Biology or Microbiology.
3 years of experience in the medical industry.
Area of expertise in clinical and microbiological analysis laboratories.
Knowledge of ISO 14644 and ISO 14698, ISO 11135, 17025 and ISO 11137.
Knowledge of advanced statistical techniques, microbiology test methods, Good Laboratory Practices.
Knowledge of cleanroom technology (balancing, functionality, filtration).
Knowledge of ethylene oxide gas and radiation sterilization methodology.
Bilingual
Management of computer packages (Excel, Word, Power Point)
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.
Medtronic 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.
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