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.
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.
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.
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
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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