Design Assurance Engineer (Medtech)

TL;DR

Design Assurance Engineer (Medtech): Ensuring quality standards throughout the new product development lifecycle for interventional cardiology therapies with an accent on design verification, risk management, and regulatory compliance. Focus on collaborating with cross-functional teams to translate customer needs into high-quality medical solutions and supporting internal and external audits.

Location: Galway, Ireland

Salary: €49,920–€74,880

Company

A global leader in healthcare technology dedicated to alleviating pain, restoring health, and extending life through innovative medical solutions.

What you will do

• Represent the Design Assurance function within cross-functional product development projects.
• Prepare and execute test method validations, design verification protocols, and shelf-life reports.
• Manage and complete risk management documentation for new products.
• Provide quality input for process improvements and change control activities.
• Support internal and external audits to ensure regulatory compliance.
• Collaborate with internal and external stakeholders to address technical problems and quality issues.

Requirements

• Bachelor’s degree with at least 2 years of relevant experience in Quality Engineering or Science, or a Master’s degree in a technical discipline.
• Experience working in a highly regulated industry, preferably medical devices.
• Proven ability to work with cross-functional groups to lead deliverables and apply critical thinking.
• Experience in complaint handling or post-market quality teams.
• Strong understanding of regulatory compliance requirements for product design and development.

Culture & Benefits

• Competitive salary and flexible benefits package.
• Eligibility for the hirify.global Incentive Plan (MIP).
• Opportunity to work on life-changing medical technology.
• Commitment to diversity, equity, and inclusion.
• Support for career growth and professional development.