Design Quality Engineer II RPE - Mervue

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.

A Day in the Life

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.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 Design Quality Engineer II 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:

Responsibilities may include the following and other duties may be assigned.

• 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

• 2+ years of Quality experience with a Bachelors Degree
• 0+ 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  
• Familiar with 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. 

• Previous experience in Software V&V. 

• Working knowledge / education on Electronic Schematics, circuit simulation and analysis, PCB Assembly Drawings. 

• Familiar with IEC 60601 and product specific industry standards. 

• Understanding of 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), 

• Experience of Stability evaluations, Biocompatibility assessments, Sterilization, Transportation Testing. 

• DFSS [Design for Six Sigma] or DRM [Design for Reliability and Manufacturability] Green Belt.

Medtronic offer a competitive salary and flexible Benefits Package

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: 48,000.00 EUR - 72,000.00 EUR |  

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

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