Microbiologist Sterilization Specialist II

Medtronic•Grand Rapids, MI

3d•Onsite

About The Position

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 Act boldly. Compete to win. Move with speed and decisiveness. Foster belonging. Deliver results…the right way. That’s the Medtronic Mindset — our cultural norms. Our brand is rooted in action, not just words. The Medtronic Mindset defines the expectations of our culture. Every person here plays a role in bringing it to life. We recognize your extraordinary potential to ensure future generations live better, healthier lives. The Grand Rapids site, which manufactures cardiac surgery devices distributed worldwide, is seeking a Microbiologist-Sterilization Specialist to support sustained compliance and continuous improvement initiatives, playing a critical role in ensuring site microbiology and sterilization operations meet regulatory and quality expectations. Join a team of passionate microbiologists who each play a critical role in ensuring the parts we manufacture are safe and compliant. At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. In-person exchanges are invaluable to our work. We’re working a minimum of 5 days a week onsite as part of our commitment to fostering a culture of professional growth and cross-functional collaboration as we work together to engineer the extraordinary. Responsibilities may include the following and other duties may be assigned. Understand and implement policies that ensure compliance for controlled environments on-site in accordance with ISO 14644 series. Follow protocols and regulations in order to clean, store, and/or deliver products, supplies, and/or instruments. Interpret and evaluate the analyses in terms of accuracy and precision compared against established specifications and recommends and implements corrective action where necessary. Perform review of microbiology laboratory tests and ensure product families are appropriately tested at set frequencies. Support internal microbiology lab as needed with analyzing chemical, biological or microbiological products, raw materials, in-process materials, release test samples or stability samples in support of the company's quality program. Develop, validate, and implement controlled environment methods and overall site contamination control. Apply existing techniques and procedures with recommendations and implementation of modification for improved efficiency, or devise and develop new analytical methods and techniques. Perform 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 projects. Prepare for internal and external audits and ensure manufacturing areas are compliant with internal work instructions. This includes performing quality walks and periodic assessment of internal processes. Perform corrective and preventative actions to support manufacturing nonconformances and close gaps from audits. Prepare, clean, disinfect, and/or sterilize instruments, materials, products, and/or supplies. Support change control of internal work instructions and policies to align with industry best practices.

Requirements

Bachelor’s degree in science or technical field with 2+ years of work experience in microbiology, sterilization, and/or biocompatibility experience OR Advanced degree in science or technical field with 0+ years of work experience in microbiology, sterilization, and/or biocompatibility experience
For Baccalaureate degrees earned outside of the United States, a degree that satisfies the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A) is required.

Nice To Haves

Experience in a cleanroom environment, preferably in medical device, pharmaceutical, or biotech manufacturing.
Knowledge of cleanroom classifications (ISO Class 7–8) and contamination control practices.
Experience with BET testing
General understanding working with EO sterilization
CISS certification, AAMI WG, or other external body training certifications
Working knowledge of trending data software (Minitab, Excel, etc.) and performing statistical analysis
Flexible and open minded regarding daily task requirements and prioritizing projects
Able to work collaboratively and efficiently in both a team environment and individually on specific projects
Strong understanding of Microsoft apps (Excel, Word, etc.)

Responsibilities

Understand and implement policies that ensure compliance for controlled environments on-site in accordance with ISO 14644 series.
Follow protocols and regulations in order to clean, store, and/or deliver products, supplies, and/or instruments.
Interpret and evaluate the analyses in terms of accuracy and precision compared against established specifications and recommends and implements corrective action where necessary.
Perform review of microbiology laboratory tests and ensure product families are appropriately tested at set frequencies.
Support internal microbiology lab as needed with analyzing chemical, biological or microbiological products, raw materials, in-process materials, release test samples or stability samples in support of the company's quality program.
Develop, validate, and implement controlled environment methods and overall site contamination control.
Apply existing techniques and procedures with recommendations and implementation of modification for improved efficiency, or devise and develop new analytical methods and techniques.
Perform 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 projects.
Prepare for internal and external audits and ensure manufacturing areas are compliant with internal work instructions. This includes performing quality walks and periodic assessment of internal processes.
Perform corrective and preventative actions to support manufacturing nonconformances and close gaps from audits.
Prepare, clean, disinfect, and/or sterilize instruments, materials, products, and/or supplies.
Support change control of internal work instructions and policies to align with industry best practices.

Benefits

Medtronic offers a competitive Salary and flexible Benefits Package
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
Simple Steps (global well-being program)
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)
Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums)