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.OverviewInterventional Cardiology Therapies (ICT) are a key part of the Medtronic portfolio, focused on addressing unmet needs in the growing areas of complex Percutaneous Coronary Intervention (PCI), Renal Denervation (RDN), and Structural Heart therapies. The Design Assurance team is committed to maintaining the highest quality standards throughout new product development, from early concept through verification. By translating design requirements and customer needs into innovative solutions, the team partners with cross‑functional colleagues to deliver high‑quality products that meet patient and customer expectations.ResponsibilitiesServe as the Design Assurance representative on PDP projects, with dotted‑line reporting to the Quality Core Team Member.Collaborate effectively across a matrixed team to align priorities, solve problems, and achieve project goals.Work independently to plan and schedule your own activities, which are necessary to meet timelines.Communicate progress to project leadership regularly, presenting complex issues in a clear, concise, and actionable way.Perform reliability analyses across requirements, architecture, interfaces, and design using tools such as FTA, failure trending, and reliability forecasting to assess product and process robustness.Lead risk management activities to ensure compliance with FDA, ISO 14971:2019, and ISO 13485:2016 requirements.Lead and complete complex test method validation activities for system and capital equipment test methods, including operator training, validation study design and sample size definition, data analysis (including crossed gage R&R, ANOVA, and probability of misclassification), reduction of variation sources, and report writing.Drive continuous improvement in Design Assurance to boost efficiency, effectiveness, and compliance.Key Skills & ExperienceDemonstrates advanced expertise in the field, with broad and in depth knowledge typically gained through a combination of higher education and relevant experience.Holds a minimum Level 8 degree in Engineering or a related discipline, with at least 7 years of relevant experience or holds an advanced degree with a minimum of 5 years of relevant experience.Practical project management knowledge is desirable.Experience in a highly regulated environment, ideally within the medical device industry.Proven ability to resolve complex issues through collaboration with cross‑functional teams.Demonstrated ability to work effectively in a matrix organization and navigate complex business systems, regulations, standards, and performance requirements.Knowledge of reliability tools and practices that support requirements, design, integration, verification, and validation.Strong critical thinking skills, with a focus on improving system performance and delivering positive business outcomes.Excellent communication skills and the ability to influence others are essential for success in this role.Experience managing complex data sets and conducting statistical analysis.Benefits & CompensationMedtronic offers a competitive salary and flexible benefits package tailored to support you at every career and life stage. Pay range (Ireland): 64,640.00 EUR – 96,960.00 EUR. This position is eligible for a short‑term incentive called the Medtronic Incentive Plan (MIP).EEO StatementIt 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.
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