Senior Design Quality Engineer - RPE - Mervue
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Senior Design Quality Engineer - RPE - Mervue
role at
Medtronic
.
Location: Galway, County Galway, Ireland.
At Medtronic, you can begin a life-long career of exploration and innovation, and help champion healthcare access and equity for all.
You'll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.
Key Responsibilities
Critically review new and modified product designs to determine their impact on patient safety, standards compliance, and reliability.
Ensure that design changes to existing products comply with Medtronic's QMS, ISO*****, 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.
Key Skills & Experience
4+ years of Quality experience with a Bachelors Degree
2+ years of Quality experience with a Masters Degree
Experience in the Medical Device Industry or a similar role.
Good verbal and written communication skills in English, including protocol / report development and review.
Experience in ISO *****
Experience in Risk Management ISO *****
Working knowledge of IEC standards.
Familiar with IEC ***** and product specific industry standards.
Experience with EU-MDR regulations.
Experience with verification/validation test plan development.
Experience with CAPA and root cause failure analysis.
Nice to have
Previous experience in Electronic, PCB design, Hardware.
Working knowledge of Electronic Schematics, circuit simulation and analysis, PCB Assembly Drawings.
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 or Black Belt.
Medtronic Offers a Competitive Salary and Flexible Benefits Package
Pay range: Ireland: 62,****** EUR - 93,****** EUR.
This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).
Benefits & Compensation
Medtronic offers a competitive salary and flexible benefits package designed to support you at every career and life stage.
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.
Seniority level
Mid-Senior level
Employment type
Full-time
Job function
Quality Assurance
Industries: Medical Equipment Manufacturing, Hospitals and Health Care, and Pharmaceutical Manufacturing
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