ENVIROMENTAL& STERILIZATION ENGINEER II

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 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.
• May also be involved in establishing requirements for the transfer of methodology from R&D.

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:

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Bachelor’s Degree in Biomedical Engineering, Chemical Engineering, or a related discipline.

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Minimum of 5 years of experience within the medical device industry with knowledge of regulatory and quality system requirements.

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Solid understanding of sterilization process methodologies, including Ethylene Oxide (EtO) and radiation sterilization.

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Experience in microbiological and sterility testing methods, including Bioburden and Sterility Suitability (Bacteriostasis & Fungistasis – B&F).

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Experience performing Bacterial Endotoxin testing and microbiological laboratory analysis.

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Knowledge and hands-on experience with EO Biological Indicators, including validation, handling, and interpretation.

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Strong knowledge of international standards including ISO 14644, ISO 14698, ISO 11135, and ISO 11137.

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Experience with cleanroom technology, including airflow balancing, system functionality, and filtration systems.

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Experience in the development, execution, and documentation of EO sterilization validation and revalidation activities.

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Proficiency in advanced statistical techniques for data analysis, process monitoring, and continuous quality improvement.

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Advanced English communication skills for technical documentation, reporting, and cross-functional collaboration.

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. 

Benefits & Compensation

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.
 

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