Principal Design Assurance Engineer (PVH)

Medtronic; Galway; Hybrid; EUR 90,000 - 130,000; Full time

Benefits offered by this job

Competitive salary

Benefits package

Hybrid work

Job summary

Medtronic plc in Galway is seeking a Principal Engineer to lead risk management, reliability, design verification and shelf-life protocols. You will mentor junior engineers and ensure regulatory compliance across FDA, ISO standards.

This hybrid role requires four onsite days per week and close collaboration with multiple teams. The successful candidate will hold an NFQ Level 8 Engineering degree (7+ years of relevant experience) or an advanced degree with 5+ years, with DRM certification

Qualifications

• Requires an advanced engineering degree with 7+ years of related experience.
• NFQ Level 8 in Engineering or related discipline; advanced degree acceptable.
• DRM certification is advantageous.

Responsibilities

• Lead risk management, reliability, design verification and shelf-life workstreams.
• Mentor junior engineers on the project and within the department.
• Maintain up-to-date knowledge of regulatory requirements (FDA, ISO 14971/13485).
• Collaborate with internal and external stakeholders to build partnerships.
• Provide technical guidance on component qualification (PPAP).
• Ensure design quality activities align with project goals.
• Support cross-functional teams across design and development.

Skills

Regulatory knowledge

Project management

Cross-functional collaboration

Communication skills

Education

NFQ Level 8 Engineering degree

Advanced degree (optional)

Tools

Design for Six Sigma (DRM)

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

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

Peripheral Vascular Health offers a diverse portfolio of devices and therapies to restore the right blood flow to the right patient. Peripheral Vascular Health therapies treat patients with Peripheral and Carotid Artery Disease, End-Stage Renal Disease, Superficial and Deep Venous Diseases, and a variety of conditions treated with Peripheral Embolization. The operating unit leads the way in the Superficial Venous, Deep Venous Stenting, and Drug- Coated Balloon markets, caring for nearly 1 million patients globally with lifesaving and life-enhancing therapies. This position is hybrid with a 4 day per week onsite requirement.

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.

• You will act as an extended team member on a PDP Project, representing the Design Assurance function and reporting indirectly to the quality lead on the project.
• You will lead strategies for Risk Management, Reliability, Design Verification and Shelf-Life Protocols / Reports.
• You will maintain expert, up to date knowledge of developments in regulatory compliance requirements for product design, development, transfer and commercialisation activities.
• You will collaborate with various departments both internally and externally to build strong partnerships.
• You will provide technical guidance to development team for component qualification (PPAP).
• Understand risk management concepts used throughout the quality system to successfully meet FDA, ANSI/AAMI/ISO 14971:2019, and ANSI/AAMI/ISO 13485:2016 requirements
• As a principal engineer, you will be expected to mentor more junior engineers on the project and within the Department.

Key Skills & Experience

• Requires advanced knowledge of job area combining breadth and depth, typically obtained through advanced education combined with experience.
• Requires a minimum NFQ Level 8 Degree in Engineering or other relevant discipline and minimum 7 years of relevant experience.
• Or advanced Degree with a minimum of 5 years of relevant experience.
• Certification in Design for Six Sigma (DRM) is advantageous.
• Practical knowledge of project management tools and practices.
• Experience in a medical device design quality, design assurance or reliability.
• Experience with solving complex issues by interacting with cross functional groups.
• Demonstrated critical thinking skills with focus on improved system performance outcomes and positive business impact.
• Excellent communication and ability to influence is critical to the role.
• Excellent communication skills and the ability to influence are critical for this role.
• Fluency in English, both written and spoken, is required.

Medtronic offer a competitive salary and flexible Benefits Package

#INDJ #LI-Onsite

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.