Principal Sterilization Engineer – Ethylene Oxide

Medtronic • Fridley, MN

8d • Remote

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 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. In this role, you will work within the Strategy & Technology - Sterilization organization to enable and transform sterilization across Medtronic. You will serve as a subject matter expert for ethylene oxide sterilization. You will have a primary focus within a team validating Ethylene Oxide (EO) processes to achieve optimization objectives. You will serve within various project teams and partner with cross-functional stakeholders. At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. This position is remote to enhance our competitive edge and expand our cross-functional collaboration efforts. This role will require up to 25% of travel to enhance collaboration and ensure successful completion of projects.

Requirements

• Bachelor’s Degree and 7+ years of Sterilization experience OR Master’s Degree and 5+ years of experience OR PhD and 3+ years of experience
• Degree in Engineering, Microbiology or related technical discipline
• Ethylene Oxide (EO) Sterilization experience

Nice To Haves

• Degree in Engineering, Microbiology or related field
• Familiarity with FDA, EU and other international regulations, standards and guidelines governing sterilization of medical devices
• Experience developing, validating & implementing sterilization processes
• Experience conducting comparative resistance studies, load configuration assessments, coordinating with laboratory testing and authoring validation documentation
• Experience with sterilization parametric release processing
• Experience analyzing sterilization documentation, monitoring data & batch records
• General understanding of sterilization equipment, control systems and cycle programming / definition
• Leadership skills, managing major / moderately complex projects, including delegation of work and review of work products, at times acting as a team leader
• Experience and knowledge of ISO 11135 & referenced standards
• Experience in the Medical Device or Pharmaceutical industry
• Experience developing EO sterilization processes & parametric monitoring specifications
• Ability to work in a team environment, including cross-functional teams, and exert influence while maintaining a cohesive team
• Ability to apply advanced scientific principles and statistical techniques
• 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.

Responsibilities

• Serves as subject matter expert (SME) for EO sterilization initiatives
• Serves as lead SME within the core team developing, validating & implementing new EO sterilization processes
• Provides technical expertise in the characterization, development/definition, and validation of EO sterilization equipment & processes.
• Manages large projects or processes with limited oversight from manager.
• Navigate within the QMS to document validation activity
• Creates & executes validation documentation with full stakeholder alignment covering product scope, resistance hierarchy, process equivalency, performance qualifications, etc.
• Ensures compliance and regulatory support provided for all validation activities completed
• Identifies adequate process monitoring specifications, including parametric release establishment
• Works with product/packaging stakeholders to evaluate product limitations & determine EO sterilization processing bounds
• Interprets and evaluates data to drive action
• Interfaces with manufacturing organization & respective stakeholders to validate, implement & handoff sterilization processes
• Provides technical support to the product design teams and manufacturing sites
• Provides feedback and recommendations to management on sterilization initiative performance, goals, and status
• Develops solutions to moderately complex problems, and/or makes moderate to significant improvements of processes, systems or products independently to enhance performance of job area.
• Implements solutions to problems
• Reviews quality data and assesses sterilization and microbiological quality
• Travel up to 25% in support of initiatives

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)

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees