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Senior Design Quality Engineer at Medtronic · Galway
Job Description
Senior Design Quality Engineer
Location: Galway, County Galway, Ireland · Flexible Work Arrangement
Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first — developing innovative medical technologies that improve the lives of 72+ million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact.
A Day in the Life
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 Sr. Design Quality Engineer position, supporting Released Product Engineering [RPE] for the Acute Care & Monitoring [ACM] Operating Unit, is one of development, improvement, and innovation, through technical excellence and cross functional collaboration.
If you pride yourself on your problem-solving skills, meticulous attention to detail and passion for quality this may be the role for you. You will be tasked to provide quality engineering support in design and development of medical device products across the Acute Care and Monitoring [ACM] portfolio of products. Facilitating the application of design controls, Risk Management and Change Control processes in the evaluation and release of product changes.
Come for a job, stay for a career!
A Day in The Life Of:
Critically review new and modified product designs to determine their impact to existing or new product requirements and their effect on, patient safety, standards compliance, and reliability.
Ensure that design 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.
Key Skills & Experience
4+ years of Quality experience with a Bachelors Degree
2+ years of Quality experience with a Masters Degree
Specialised Skills or Experience
Experience in the Medical Device Industry or a similar role.
Good verbal and written communication skills through English, including protocol / report development and review.
Experience in ISO 13485
Experience in Risk Management ISO 14971
Working knowledge of IEC standards.
Familiar with IEC 60601 and product specific industry standards.
Experience of EU-MDR regulations.
Experience of 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 offer a competitive salary and flexible Benefits Package
#LI-Hybrid
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.
Recruitment Fraud Alert
We are aware of phishing scams targeting job seekers. Please keep the following in mind:
Apply only through official Medtronic channels. All legitimate Medtronic recruiting communications come from approved Medtronic platforms and official @medtronic.com email addresses.
Medtronic will never ask for payment or sensitive personal information (such as bank account or Social Security details) during early stages of the hiring process. Any such requests are not legitimate.
If you receive a suspicious message claiming to be from Medtronic, do not respond, click links, or open attachments.
If you have any questions, concerns regarding the authenticity of a communication alleged to have been made by or on behalf of Medtronic, please contact us immediately at AskHR@medtronic.com.
Benefits & Compensation
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.