€78,640 – €118KSeniorFull Time
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.
Medtronic
At Medtronic, we value what makes you unique. Be part of a company that thinks differently to solve problems, make progress, and deliver meaningful innovations.
Our Purpose
The principal EO sterilization engineer works within the S&T-Sterilization technical organization to enable and transform sterilization across Medtronic. The position will serve as a subject matter expert for ethylene oxide sterilization. The position will have a primary focus within a team validating EO processes in order to achieve optimization objectives. The position will serve within various project teams and partner with cross-functional stakeholders.
Come for a job, stay for a career!
A Day in The Life Of:
Responsibilities may include the following and other duties may be assigned.
Serves as subject matter expert (SME) for ethylene oxide (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.
Travel <25% in support of initiatives.
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.
Other duties may be assigned.
Key Skills & Experience
Minimum NFQ level 8 Bachelor’s of Science degree in Engineering, Microbiology, or related technical discipline.
Years of Experience:
7+ years relevant experience or 5+ years relevant experience with advanced degree.
Specialized Knowledge or Skills Required:
Familiarity with FDA, EU and other international regulations, standards and guidelines governing sterilization of medical devices.
Understanding of gas sterilization methods.
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.
Strong written, verbal communication skills.
Desired/Preferred Qualifications:
Direct experience with EO sterilization processes, equipment, controls & change management.
Experience and knowledge of ISO 11135 & referenced standards.
Experience in the Medical Device or Pharmaceutical industry.
Experience developing EO sterilization processes & parametric monitoring specifications.
Excellent problem-solving skills.
Proven project management and interpersonal skills.
Excellent organizational and judgment skills.
Ability to work in a team environment, including cross-functional teams, and exert influence without alienating others.
Computer proficiency using word processors, spreadsheet, and project management.
Ability to apply advanced scientific principles and statistical techniques.
Medtronic offer a competitive salary and flexible Benefits Package
#INDJ
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.
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.
Pay range / Rango salarial / Intervalo salarial /Fascia retributiva / Tranche de salaire / Gehaltsband / Salaribereik: Ireland: 78,640.00 EUR - 117,960.00 EUR |
This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).
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
