Senior Design Quality Engineer

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

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

TheSr.Design Quality Engineerposition,supporting Released Product Engineering[RPE] for theAcuteCare & Monitoring [ACM]Operating Unit,is one of development, improvement, and innovation, throughtechnical excellence andcross 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.Facilitatingthe 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 todeterminetheir impact to existing or new product requirements and their effect on, patient safety, standards compliance, and reliability.

• Ensure thatdesignchanges 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).

• Assistin the creation of verification andvalidationtest plans,protocolsand reports. Review testing and analysis for standards and productrequirementscompliance.

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

#LI-Hybrid

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.

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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.