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Engineering the extraordinary
Principal Sterilization Engineer – Ethylene Oxide
Location
United States
Posted
80 days ago
Salary
$118K - $177K / year
Seniority
Lead
No structured requirement data.
Job Description
Principal Sterilization Engineer – Ethylene Oxide
Medtronic
We anticipate the application window for this opening will close on - 6 Apr 2026 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. - 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 Must Haves - 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 Have - 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. 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. The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. U.S. Work Authorization & Sponsorship At Medtronic, we are committed to fostering an environment where employees can thrive and make a meaningful impact. In alignment with our enterprise-wide workforce planning approach, U.S. work authorization sponsorship (H-1B, TN, J, etc.) is offered exclusively for Principal-level roles and above, where specialized expertise aligns with long-term business needs. Roles below the Principal level require candidates to possess unrestricted U.S. work authorization at the time of hire and for the duration of employment. Join us in our mission to alleviate pain, restore health, and extend life—where your unique background and perspective are valued. 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. Salary ranges for U.S (excl. PR) locations (USD):$118,400.00 - $177,600.00 This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP). The base salary range is applicable across the United States, excluding Puerto Rico and specific locations in California. The offered rate complies with federal and local regulations and may vary based on factors such as experience, certification/education, market conditions, and location. Compensation and benefits information pertains solely to candidates hired within the United States (local market compensation and benefits will apply for others). The following benefits and additional compensation are available to those regular employees who work 20+ hours per week: 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, and Simple Steps (global well-being program). The following benefits and additional compensation are available to all regular employees: 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), and Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums). Regular employees are those who are not temporary, such as interns. Temporary employees are eligible for paid sick time, as required under applicable state law, and the Employee Stock Purchase Plan. Please note some of the above benefits may not apply to workers in Puerto Rico. Further details are available at the link below: Medtronic benefits and compensation plans 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. It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities. If you are applying to perform work for Medtronic, Inc. (“Medtronic”) in any position which will involve performing at least two (2) hours of work on average each week within the unincorporated areas of Los Angeles County, you can find here a list of all material job duties of the specific job position which Medtronic reasonably believes that criminal history may have a direct, adverse and negative relationship potentially resulting in the withdrawal of a conditional offer of employment. Medtronic will consider for employment qualified job applicants with arrest or conviction records in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.
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