A Day in the Life
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 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.
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
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 offers a competitive Salary and flexible Benefits Package
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: 62,320.00 EUR - 93,480.00 EUR
This position is eligible for a short‑term incentive called the Medtronic Incentive Plan (MIP).
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.
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.
Learn more about our business, mission, and our commitment to diversity here
To be considered for this role you will be redirected to and must complete the application process on our careers page. To start the process click the Apply button below to Login/Register.
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