Principal Design Assurance Engineer (PVH)

GAL Medtronic Vascular Galway Unlimited Company; Parkmore; Hybrid; EUR 81,000 - 122,000; Full time

Benefits offered by this job

Medtronic Incentive Plan (MIP)

Hybrid onsite work model

Job summary

Medtronic plc is hiring a Principal Engineer in Ireland to drive Design Assurance and regulatory compliance on PDP projects. You will lead risk management strategies, reliability initiatives, and design verification activities across cross‑functional teams.

The role requires mentoring junior engineers and partnering with multiple departments to ensure quality and regulatory readiness for commercialization. Hybrid work with onsite requirements supported.

Qualifications

• Advanced knowledge of design quality and reliability within medical devices.
• Experience with FDA/ISO regulatory standards (ISO 13485, 14971).
• Ability to lead risk management strategies and project teams.

Responsibilities

• Act as an extended team member on PDP projects, representing Design Assurance.
• Lead strategies for Risk Management, Reliability, Design Verification, Shelf-Life protocols.

Skills

Design Assurance

Risk Management

Regulatory compliance

Cross-functional collaboration

Mentoring junior engineers

Project management

Communication and influencing

Education

NFQ Level 8 Degree in Engineering

Advanced Degree (optional)

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:

• 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).
• undefined 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

Medtronic offer a competitive salary and flexible Benefits Package #INDJ #LI-Onsite

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.

Pay range / Rango salarial / Intervalo salarial /Fascia retributiva / Tranche de salaire / Gehaltsband / Salaribereik: Ireland: 81,120.00 EUR - 121,680.00 EUR | The final salary within this range will be determined based on objective, job-related criteria, including relevant experience, skills and qualifications, in accordance with our compensation framework.

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

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. We change lives. Each team member, each day, helps to improve and redefine how the world treats the most pressing health conditions, from heart disease to diabetes. Our industry leadership comes from the passion and ingenuity of our people. That’s who we are. Working alongside one another, we use science, medicine, and a profound understanding of the human body to build extraordinary technologies that can transform lives. We build extraordinary solutions as one team. With one Medtronic Mindset defining how we work. Speed and decisiveness run through our DNA. Diverse perspectives inspire our bold answers to any challenge that comes our way. And we deliver results the right way, breakthrough after patient breakthrough. This life-changing career is yours to engineer. By bringing your ambitious ideas, unique perspective and contributions, you will… Build a better future, amplifying your impact on the causes that matter to you and the world Grow a career reflective of your passion and abilities Connect to a dynamic and inclusive culture that welcomes the challenge of life-long learning

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 settingis 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. For further information about the E-Verify program, please click here.