Principal Design Assurance Engineer (PVH)

Description

The company is a global healthcare technology business with about 95,000 staff across more than 150 countries, building medical technologies used by over 72 million patients a year.

The Peripheral Vascular Health unit makes devices and therapies that restore blood flow for patients with peripheral and carotid artery disease, end-stage renal disease, superficial and deep venous disease, and conditions treated with peripheral embolization.

The unit leads the superficial venous, deep venous stenting, and drug-coated balloon markets and cares for nearly 1 million patients worldwide.

The role sits within a team that values different ways of thinking when solving problems and delivering new products.

Responsibilities

• Act as an extended member of a PDP project team, speaking for Design Assurance and reporting indirectly to the project's quality lead.
• Set the direction for risk management, reliability, design verification, and shelf-life protocols and reports.
• Keep your knowledge of regulatory requirements for product design, development, transfer, and commercialisation current and deep.
• Build strong working relationships with colleagues across internal and external departments.
• Advise the development team on component qualification (PPAP).
• Apply risk management concepts across the quality system to meet FDA, ANSI/AAMI/ISO 14971:2019, and ANSI/AAMI/ISO 13485:2016 requirements.
• Mentor junior engineers on the project and within the department.
• Other duties may be assigned.

Requirements

• A minimum NFQ Level 8 degree in engineering or a related discipline, plus at least 7 years of relevant experience.
• Or an advanced degree plus at least 5 years of relevant experience.
• Advanced knowledge of your field, spanning both breadth and depth, usually built through advanced study and hands-on experience.
• Experience in medical device design quality, design assurance, or reliability.
• Practical knowledge of project management tools and methods.
• Experience resolving complex problems with cross-functional groups.
• Critical thinking aimed at better system performance and positive business results.
• Strong communication skills and the ability to influence others are critical for this role.
• Advantageous: certification in Design for Six Sigma (DRM).
• Fluent written and spoken English is required.

Conditions

Hybrid role requiring onsite attendance 4 days per week.

The listed duties describe the general nature and level of the work and are not exhaustive.

Benefits

• Pay range in Ireland: 81,120.00 EUR to 121,680.00 EUR.
• The final salary within this range depends on objective, job-related factors such as relevant experience, skills, and qualifications, under the company's compensation framework.
• A competitive salary and a flexible benefits package with a wide range of benefits, resources, and compensation plans to support you at each career and life stage.
• Eligible for the company's short-term incentive, the company Incentive Plan (MIP).