Software Safety Engineer II (Medtech)

TL;DR

Software Safety Engineer II (Medtech): Identifying and mitigating patient safety hazards for cardiac medical products with an accent on risk analysis and regulatory compliance. Focus on developing risk management files, executing safety engineering studies, and implementing innovative risk mitigation strategies to ensure system reliability.

Location: Onsite in Galway, Ireland

Salary: €48,000–€72,000

Company

hirify.global is a global healthcare technology leader dedicated to alleviating pain, restoring health, and extending life through engineering innovation.

What you will do

• Identify, analyze, and mitigate patient safety hazards in software for cardiac medical products in collaboration with cross-functional teams.
• Conduct comprehensive risk analyses (severity, occurrence, risk-benefit) and maintain risk management files in compliance with ISO 13485, ISO 14971, and IEC 62304.
• Lead traceability of design verification and validation within risk management documentation to meet global regulatory standards.
• Execute reliability and safety engineering studies, including Design of Experiments (DOE), to evaluate design concepts.
• Recommend and implement design improvements, test methods, and statistical process control techniques to enhance product safety.
• Develop reusable patterns and encourage innovation to increase team velocity.

Requirements

• Bachelor’s or advanced degree in engineering, math, science or a technical discipline.
• Minimum 2 years of work experience in engineering and/or quality.
• Proven understanding of product reliability and safety engineering principles.
• Experience in a highly regulated industry, preferably with implantable medical devices.
• Proficiency in Risk Management (ISO 14971) and hazard analysis techniques such as PHA, HAL, FTA, and DFMEA.
• Technical proficiency in two or more of: C++, Java, JavaScript, HTML, C#, .NET, Python, Angular, or Xamarin.

Nice to have

• Working knowledge of artificial intelligence (AI) tools.
• Experience with Design for Reliability (DfR), DRM, DFSS, or DFLS.
• Experience with Agile methodologies.

Culture & Benefits

• Competitive salary and flexible benefits package.
• Eligibility for the hirify.global Incentive Plan (MIP) short-term incentive.
• Collaborative environment with a global team of 95,000+ professionals.
• Commitment to healthcare access, equity, and lifelong career exploration.