Senior Reliability Engineer (Medical Devices)

Location: Galway, County Galway, Ireland

Salary: €64,640–€96,960 per year, plus eligibility for the hirify.global Incentive Plan.

Company

hirify.global develops and manufactures healthcare technologies, including electrophysiology products for diagnosing and treating cardiac arrhythmias.

What you will do

• Lead reliability engineering activities related to product performance issues, manufacturing events, and field complaints.
• Conduct complaint investigations, product analysis, technical assessments, and documentation of findings.
• Develop design verification strategies, test methods, sample size justifications, and product acquisition plans.
• Lead test method validation using statistical techniques and documented methodologies.
• Maintain risk management documentation, including Product Hazard Analyses, DFMEAs, Risk Management Reports, and related assessments.
• Partner with manufacturing, quality, regulatory, and engineering stakeholders to resolve technical issues and support patient safety.

Requirements

• Bachelor's degree in Engineering, Science, or a related field with at least 4 years of experience, or an advanced degree with at least 2 years of engineering or quality experience.
• Experience with technical investigations, product analysis, or reliability engineering activities.
• Experience creating, reviewing, or maintaining technical documentation in a regulated environment.
• Ability to analyze technical data, assess risk, and support evidence-based decisions.
• Experience collaborating across cross-functional teams to resolve technical issues.
• Proficiency with Microsoft Office applications, including Word, Excel, Access, and PowerPoint.

Nice to have

• Medical device industry experience.
• Knowledge of FDA 21 CFR Part 820, EU MDR 2017/745, ISO 13485, ISO 14971, and IEC 60601.
• Experience with design verification, test method development, and test method validation.

Culture & Benefits

• Competitive salary and flexible benefits package.
• Short-term incentive eligibility through the hirify.global Incentive Plan.
• Benefits and resources designed to support employees across career and life stages.
• Work within a healthcare technology environment focused on product quality and patient safety.