Senior Design Quality Engineer (Medical Devices)

Location: Galway, County Galway, Ireland; hybrid

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

Company

hirify.global is a global healthcare technology company developing medical technologies that improve patient outcomes.

What you will do

• Provide quality engineering support for medical device products within the Acute Care and Monitoring portfolio.
• Review new and modified product designs for impacts on requirements, patient safety, standards compliance, and reliability.
• Ensure product changes comply with the quality management system, ISO 13485, EU-MDR, and FDA Quality System Regulations.
• Lead cross-functional teams in developing risk management plans, risk assessments, dFMEAs, and risk management reports.
• Support the creation and review of verification and validation test plans, protocols, reports, and related analyses.

Requirements

• 4+ years of quality experience with a bachelor’s degree, or 2+ years with a master’s degree.
• Experience in the medical device industry or a similar quality engineering role.
• Experience with ISO 13485, ISO 14971 risk management, EU-MDR, CAPA, and root cause failure analysis.
• Working knowledge of IEC standards, including IEC 60601 and product-specific industry standards.
• Strong verbal and written English communication skills, including protocol and report development and review.
• Experience developing verification and validation test plans.

Nice to have

• Experience with electronics, PCB design, hardware, schematics, circuit simulation, or PCB assembly drawings.
• Knowledge of statistical techniques, sampling plans, GR&R, hypothesis testing, ANOVA, and statistical software such as Minitab.
• Experience with stability, biocompatibility, sterilization, ship testing, HALT/HASS, DMAIC, or DMADV/DFSS.
• DFSS, Lean Green Belt, or Black Belt certification.

Culture & Benefits

• Flexible benefits package.
• Competitive compensation.
• Eligibility for the hirify.global Incentive Plan short-term incentive.
• Career development within a global healthcare technology organization.