Senior Design Assurance Engineer (Medtech)

TL;DR

Senior Design Assurance Engineer (Medtech): Planning and executing Post Market Strategies for continuous product improvement within the Coronary/RDN department with an accent on regulatory compliance and risk management. Focus on maintaining ISO and FDA standards, supporting internal and external audits, and providing technical guidance to cross-functional teams.

Location: Hybrid in Galway, Ireland

Salary: €64,640 – €96,960

Company

Global leader in healthcare technology dedicated to alleviating pain, restoring health, and extending life.

What you will do

• Provide Design Assurance support for OU Sustaining and product Surveillance initiatives.
• Execute Post Market Strategies for the continuous improvement of products, methodologies, and processes.
• Ensure compliance with ISO13485/14971, 21 CFR, and Corporate Quality standards.
• Represent the department during internal and external audits (MDR, MDSAP, FDA).
• Collaborate with risk management teams and provide focused technical guidance.
• Drive engagement and mindfulness initiatives to ensure team wellbeing.

Requirements

• Bachelor’s degree in Engineering, Mechatronics, or Science with 4+ years of experience, OR a Master’s degree with 2+ years of experience.
• Must be based in or able to work in Galway, Ireland (Hybrid).
• Fluent English proficiency (written and spoken) is required.
• Working knowledge of Regulatory Standards.
• Experience working effectively in cross-functional team environments.

Nice to have

• Experience in technical writing.
• Formal knowledge of Complaint trending or Post Market Surveillance.

Culture & Benefits

• Competitive salary and flexible benefits package.
• Eligibility for the hirify.global Incentive Plan (MIP).
• Strong focus on employee wellbeing, engagement, and a purpose-driven career.
• Opportunity to work within a globally recognized medical technology leader.