Principal Reliability Engineer

About the role

Medtronic is seeking a Principal Reliability Engineer to join its Interventional Cardiology Therapies (ICT) team in Galway. You will work on commercial medical devices, ensuring reliability, safety, and regulatory compliance while collaborating with R&D, regulatory affairs, and cross‑functional teams.

Key responsibilities

• Lead root‑cause investigations for potential product issues and manage corrective and preventive actions (CAPAs).
• Perform systematic reliability analyses on features, requirements, architecture, interfaces, and designs for design changes.
• Coordinate with Regulatory Affairs on submissions and respond to regulatory queries.
• Mentor junior engineers and oversee sustaining activities.
• Apply risk‑management concepts to meet FDA, ISO 14971:2019, and ISO 13485:2016 requirements.

Required profile

• Minimum Level 8 Engineering degree (or advanced degree) with at least 5‑7 years of relevant experience.
• Experience in a highly regulated industry, preferably medical devices.
• Proven ability to work in a matrix organization and navigate complex business and regulatory systems.
• Strong critical‑thinking skills focused on system performance and business impact.

Required skills

• Reliability engineering techniques and tools.
• Risk management and ISO 14971 compliance.
• CAPA management.
• FDA and ISO 13485 regulatory knowledge.
• Project management fundamentals.