Job description
Job Description:
Job Title
Sterilization Assurance Engineer
Sterilization Assurance Engineer
Collaborate with Innovative 3Mers Around the World
Choosing where to start and grow your career has a major impact on your professional and personal life, so it’s equally important you know that the company that you choose to work at, and its leaders, will support and guide you. With a diversity of people, global locations, technologies and products, 3M is a place where you can collaborate with other curious, creative 3Mers.
This position provides an opportunity to transition from other private, public, government or military experience to a 3M career.
The Impact You’ll Make in this Role
As a Sterilization Assurance Engineer, you will have the opportunity to tap into your curiosity and collaborate with some of the most innovative and diverse people around the world.
As a Sterilization Assurance Engineer, you will have the opportunity to tap into your curiosity and collaborate with some of the most innovative and diverse people around the world.
Here, you will make an impact by:
- Performing, coordinating, executing, and summarizing all areas of sterilization validation.
- Developing, implementing, and maintaining sterilization processes, certifications, and procedures for consumer healthcare products.
- Managing stability studies and related activities with internal and external partners
- Coordinating sterilization and stability activities
Your Skills and Expertise
To set you up for success in this role from day one, 3M requires (at a minimum) the following qualifications:
To set you up for success in this role from day one, 3M requires (at a minimum) the following qualifications:
- Bachelor’s degree or higher in a Science and/or Engineering discipline (completed and verified prior to start)
- Five (5) years of experience in Quality, Quality Engineering, Product Engineering, Six Sigma and/or Manufacturing in a private, public, government or military environment
- Two (2) years of experience in a technical role in a Medical Device regulated environment in a private, public, government or military nature
- Two (2) years demonstrable working knowledge of EO (ethylene oxide) and gamma sterilization validation in a private, public, government or military environment
Additional qualifications that could help you succeed even further in this role include:
- Prior medical device and/or quality management system experience such as Food and Drug Administration (FDA) Quality System Regulation (QSR) and/or International Organization for Standardization (ISO) 13485
- Statistical knowledge and practice e.g., Design of Experiments (DOE), Sampling Plans, Statistical Process Control (SPC), Process and Product Understanding (PPU), and Lean Manufacturing
- Strong project management skills
- Able to thrive within a multi-functional product team (Quality, Manufacturing, Tech Service, Marketing, Clinical, Regulatory, etc.)
- Thorough knowledge of fundamental microbiology principles, methods, and procedures, including knowledge of bacteria morphology and staining, aseptic technique specifically as they relate to sterilization methods.
- Expertise in cGMPs and quality systems related to terminally sterilized medical devices.
- Demonstrated proficiency in the use of statistical and quality engineering tools such as exploratory data analysis, basic statistics, Gage R&R, Analysis of Variance, Failure Modes and Effects Analysis, Statistical Process Control and Capability, acceptance sampling, correlation and regression, and experimental design.
- American Society for Quality, Certified Quality Engineer (CQE) certification or willingness to obtain.
Work location:
- Work Your Way Eligible (Employee choice to work remote, on site, or hybrid)
Travel: May include up to 10% domestic/international
Relocation Assistance: Not authorized.
Must be legally authorized to work in country of employment without sponsorship for employment visa status (e.g., H1B status).
Supporting Your Well-being
3M offers many programs to help you live your best life – both physically and financially. To ensure competitive pay and benefits, 3M regularly benchmarks with other companies that are comparable in size and scope.
Chat with Max
For assistance with searching through our current job openings or for more information about all things 3M, visit Max, our virtual recruiting
Learn more about 3M’s creative solutions to the world’s problems at www.3M.com or on Twitter @3M.
Responsibilities of this position include that corporate policies, procedures and security standards are complied with while performing assigned duties.
Our approach to flexibility is called Work Your Way, which puts employees first and drives well-being in ways that enable 3M’s business and performance goals. You have flexibility in where and when work gets done. It all depends on where and when you can do your best work.
Pay & Benefits Overview: https://www.3m.com/3M/en_US/careers-us/working-at-3m/benefits/
3M is an equal opportunity employer. 3M will not discriminate against any applicant for employment on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, or veteran status.
Please note: your application may not be considered if you do not provide your education and work history, either by: 1) uploading a resume, or 2) entering the information into the application fields directly.
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