Medtronic Athlone and Bigmeadow, County Westmeath, Ireland
Overview
Join to apply for the Design Quality Engineer II - Athlone role at Medtronic.
The position is part of the Design Quality team for Released Product Engineering in the ACM [Acute Care & Monitoring] OU. The focus is on patient safety, compliance and customer needs, providing global quality engineering support in the design and development of medical device products across the ACM portfolio.
Responsibilities
* Critically review new and modified product designs to determine their impact on existing or new product requirements and their effect on patient safety, standards compliance, and reliability
* Review and implement changes to internal corporate methods and procedures
* Ensure planned projects and changes to existing products are conducted in compliance with Medtronic’s QMS, ISO13485, EU-MDR and the FDA Quality System Regulations
* Lead cross-functional teams to develop product risk management files (risk management plan, risk assessments, dFMEA, and risk management report)
* Assist in the creation of verification and validation test plans, protocols and reports
* Review testing and analysis for standards and product requirements compliance
Qualifications
* Level 8 bachelor’s degree in Engineering, Quality Management or related disciplines and minimum 2+ years of experience in a regulated industry
* Experience in ISO 13485, Risk Management ISO 14971 and EU-MDR regulations
* Knowledge of verification/validation test plan development
* Proficiency with CAPA and root cause failure analysis
* Comparative statistical techniques, sampling plans, GR&R, K-factor, hypothesis testing, ANOVA, parametric and non-parametric analysis
* Familiar with statistical software tools (Minitab, Stat Graphics, Statistical)
* Stability, Biocompatibility, Sterilization, Ship Testing, HALT/HASS
* Familiar with DMAIC or DMADV (DFSS) methodologies
* DFSS / Lean Green Belt preferred
Benefits
Medtronic offers a competitive salary and flexible benefits package. This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).
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. Learn more about our business, mission, and our commitment to diversity here.
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