Senior Design Quality Engineer

Medtronic; Galway; On-site; EUR 65,000 - 97,000; Full time

Benefits offered by this job

Competitive benefits package

Job summary

Medtronic, a global leader in healthcare technology, is seeking a Senior Design Quality Engineer to support Released Product Engineering for the Acute Care & Monitoring unit. You will ensure design changes meet QMS, risk management, and regulatory requirements while collaborating across functions to deliver safe, compliant medical devices.

Join a team focused on technical excellence and continuous improvement, applying design controls, risk assessments, and CAPA in the evaluation and release of

Qualifications

• Experience in the Medical Device Industry or a similar role.
• Good verbal and written communication skills in English.
• Experience in ISO 13485.
• Experience in Risk Management ISO 14971.
• Working knowledge of IEC standards.
• Familiar with IEC 60601 and product standards.
• Experience of EU-MDR regulations.
• Experience of CAPA and root cause failure analysis.

Responsibilities

• Critically review new and modified product designs to determine impact on requirements, patient safety, standards compliance and reliability.
• Ensure design changes to existing products are compliant with QMS, ISO13485, EU-MDR and FDA Quality System Regulations.
• Lead cross-functional teams to develop product risk management files (risk 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

Cross-functional teams

Problem solving

English communication

Education

Bachelor's Degree

Master's Degree

Tools

ISO 13485

ISO 14971

IEC standards

EU-MDR

CAPA

Verification & Validation

Job description

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

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.

Physical Job Requirements

Medtronic offer a competitive salary and flexible Benefits Package

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.

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.

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