Principal Reliability Engineer (Medtech)

TL;DR

Principal Reliability Engineer (Medtech): Managing root cause investigations and implementing changes for commercial medical products with an accent on reliability analysis and risk management. Focus on solving complex system issues, ensuring compliance with FDA/ISO standards, and mentoring junior engineers.

Location: On-site (minimum 4 days per week) in Galway, Ireland

Salary: 81,120 - 121,680 EUR

Company

hirify.global is a global leader in healthcare technology focused on alleviating pain, restoring health, and extending life.

What you will do

• Lead root cause investigations for commercial product potential issues in collaboration with R&D.
• Implement changes, including testing and evaluation of requirements on commercial products.
• Manage CAPAs and investigations for identified product issues.
• Perform systematic reliability analysis on features, architecture, interfaces, and designs.
• Collaborate with Regulatory Affairs on submissions and regulatory body queries.
• Coordinate work and mentor junior engineers for sustaining activities.

Requirements

• Degree in Engineering or relevant discipline (Level 8 or advanced).
• Minimum 7 years of relevant experience (or 5 years with an advanced degree).
• Experience in a highly regulated industry, preferably medical devices.
• Knowledge of reliability tools and risk management standards (FDA, ANSI/AAMI/ISO 14971:2019, ANSI/AAMI/ISO 13485:2016).
• Ability to operate in a matrix organization and influence cross-functional groups.

Culture & Benefits

• Competitive salary and flexible benefits package.
• Eligibility for the hirify.global Incentive Plan (MIP) short-term incentive.
• Opportunity to work for a purpose-driven global leader in healthcare.
• Environment focused on meaningful innovation and professional growth.