Senior Design Quality Engineer

Medtronic; Galway; Hybrid; EUR 65,000 - 97,000; Full time

Job summary

Medtronic in Galway, Ireland, is seeking a Sr. Design Quality Engineer to support Released Product Engineering for the ACM unit.

You will drive design controls, risk management, and change control across medical device products, ensuring compliance with ISO 13485, EU-MDR, and FDA QSR. You will lead cross-functional teams to build risk management files, verify and validate tests, and review designs for patient safety and reliability.

Qualifications

• 4+ years of Quality experience with a Bachelor's Degree.
• 2+ years of Quality experience with a Master's Degree.
• Experience in the Medical Device Industry or a similar role.
• Good verbal and written communication skills in English, including protocol/report development.

Responsibilities

• Critically review new and modified product designs for patient safety, standards compliance, and reliability.
• Ensure design changes comply with Medtronic's QMS, ISO13485, EU-MDR and FDA QSR.
• Lead cross-functional teams to develop product risk management files (risk management plan, risk assessments, dFMEA, 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.

Skills

Quality experience

English communication

Education

Bachelor's Degree

Master's Degree

Job description

Flexible Work Arrangement
Galway, County Galway, Ireland
Full time
R75832

A Day in the Life

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.

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

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

Pay range / Rango salarial / Intervalo salarial /Fascia retributiva / Tranche de salaire / Gehaltsband / Salaribereik: Ireland: 64,640.00 EUR - 96,960.00 EUR

This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).

We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.

Build

• Build a better future, amplifying your impact on the causes that matter to you and the world
• Grow a career reflective of your passion and abilities
• Connect to a dynamic and inclusive culture that welcomes the challenge of life-long learning

Experiences that put people first

Respect for people is the hallmark of our humanity. It fuels our team to positively impact even a single life. And it means we put our people first at Medtronic as well, creating a culture of belonging and always pushing to get you the career-building resources you need.

Life-transforming technologies

No matter your role, you contribute to technologies that transform lives. What we build empowers patients to live life on their terms.

Better outcomes for our world

Here, it's about more than the bottom line. Our Mission to improve human welfare drives us. We advance healthcare, society, and equity with every design, inside and outside our walls.

Insight-driven care

Fresh viewpoints. Cutting-edge AI, data, and automation. You're shaping the future of healthcare technology and defining the next generation of breakthroughs in care

It 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.

For sales reps and other patient facing field employees, going into a healthcare setting is considered an essential function of the job and we expect our employees to comply with all credentialing requirements at the hospitals or clinics they support.

This employer participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here.