Senior Design Quality Engineer

IE5 COV - Nellcor Puritan Bennett IRL; Galway; On-site; EUR 65,000 - 97,000; Full time

Job summary

Medtronic is seeking a Sr. Design Quality Engineer in Ireland to support Released Product Engineering for the Acute Care & Monitoring unit.

You will lead cross-functional teams, assess risk management files, and ensure compliance with ISO13485, EU-MDR, and FDA standards while advancing product quality across ACM portfolio. The role requires strong problem-solving, attention to detail, and expertise in design controls, verification/validation, and CAPA processes to improve patient safety and

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.
• Excellent verbal and written English communication; protocol/report development.

Responsibilities

• Critically review new and modified product designs to determine impact on requirements, patient safety, standards compliance, and reliability.
• Ensure design changes comply with Medtronic's QMS, ISO13485, EU-MDR and FDA QSRs.
• Lead cross-functional teams to develop product risk management files (risk management plan, risk assessments, dfMEA, risk management report).
• Assist in creation of verification and validation test plans, protocols and reports.
• Review testing and analysis for standards and product requirements compliance.

Skills

ISO 13485

Risk Management

CAPA & RCA

EU-MDR

IEC Standards

Education

Bachelor's Degree

Master's Degree

Tools

Minitab

Stat Graphics

Statistical Software

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 Medtronic

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!

Key Responsibilities

• 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

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

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.