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.

-Work independently with guidance and direction from senior members of the team and manager.
-Provide understanding of the audit process including types of audits, planning, preparation, execution and follow-up.
-Perform, coordinate, execute and summarize sterilization requalification (EO, radiation, steam and chemical sterilization).
-Work with little guidance to maintain sterilization processes, certifications and procedures for the sterilization operations.
-Support internal and external audits.
-Review engineering change orders and define microbiology or sterilization risks.
-Support in the resolution of non-conformances and implement corrective action.
-Work with facility maintenance and other departments for any Sterilizer and CEA improvement/corrective activities.
-Participate in special projects as assigned.
-Reviews change control notifications for impact to sterilization/microbial testing.
-Assuring that the Microbiology / Sterilization function is maintained per industry standards.

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: Entry-level individual contributor on a project or work team.
Works with close supervision.

Organizational Impact: Delivers work of limited scope, typically smaller, less complex projects or related activities.

Innovation and Complexity: Identifies, defines and addresses problems that are not immediately evident but typically not difficult or complex.
Makes minor changes in systems and processes to solve problems.

Communication and Influence: Communicates primarily with internal contacts within immediate group.
Contacts others to gather, confirm and convey information.

Leadership and Talent Management: N / A – job at this level is focused on self-development.

Required Knowledge and Experience:

Bachelor's degree

0–2 years of engineering experience in manufacturing or sterilization, preferably in a regulated industry (medical devices, pharmaceuticals, biotechnology, or similar).
Basic experience in manufacturing, sterilization, or laboratory processes.
Experience participating in change control processes, including reviewing technical documentation and coordinating with functional areas.
Ability to analyze and understand complex technical reports, including process validation reports.
Experience reviewing or supporting activities related to process validations, technical documentation, or process engineering is desirable.
Ability to work independently, researching technical and regulatory information as needed.
Effective communication skills in both English and Spanish, written and verbal, for interaction with global teams and reviewing technical documentation.

Nice to have:

Basic knowledge of sterilization processes (Ethylene Oxide)
Familiarity with environments regulated under GMP, FDA, or ISO 13485.
Ability to analyze data and resolve technical problems.
Ability to work in multidisciplinary teams (quality, manufacturing, external suppliers).

 

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