Senior Design Quality Assurance Engineer

Hero Recruitment

  • Galway
  • Permanent
  • Full-time
  • 24 days ago
Join a global leader at the forefront of medical innovation. We are currently seeking a Senior Design Quality Assurance Engineer on a permanent basis to help drive product excellence and regulatory compliance across a diverse interventional cardiology portfolio.This is a high-impact opportunity to take ownership of quality-driven projects, mentor others, and contribute directly to improving patient outcomes through robust design and engineering practices.Job PurposeAs a key member of the Design Quality Assurance team, you will be responsible for ensuring compliance, product safety, and design integrity across a range of technologies, with a primary focus on the drug-coated balloon product line.You will also support post-market activities and lead quality projects related to material continuity, regulatory compliance, and design Value Improvement Projects (VIPs). This role includes providing mentorship and oversight to junior engineers within your reporting structure, guiding small to medium-sized sustaining projects.Key Responsibilities
  • Lead design change projects, from scope definition through to implementation, ensuring full compliance with applicable quality and regulatory standards.
  • Apply in-depth knowledge of Design Control and Design Assurance processes to ensure quality deliverables across the project lifecycle.
  • Address and resolve PIRs, CAPAs, NCEPs, and respond to regulatory updates.
  • Collaborate with cross-functional partners, including R&D, Regulatory Affairs, Clinical Risk, Medical Safety, and Operations.
  • Lead updates to Risk Management documentation, including Hazard Analyses, Use Error Analyses, and Design FMEAs.
  • Provide technical input and decision-making based on sound data analysis and problem-solving methodologies.
  • Ensure compliance with internal SOPs/WIs and external regulations (e.g., EU/FDA/Global guidance).
  • Support and contribute to internal and external regulatory audits.
  • Lead or contribute to post-market surveillance efforts, including:
  • Field Signal Evaluations
  • Performance assessments
  • PSURs
  • Regulatory Q&A
  • Provide coaching and project oversight to engineers within your reporting line, supporting their development and project success.
Technical & Educational Requirements
  • NFQ Level 8 degree in a STEM discipline.
  • Minimum 6 years of industry experience, ideally with a focus on Design Assurance.
  • Solid background in:
  • Design control, risk management, and design changes
  • Navigating and applying regulatory standards
  • Strong analytical, technical, and documentation skills.
  • Excellent communication and collaboration across cross-functional teams.
  • Demonstrated ability to work effectively both independently and within teams.
  • Highly motivated, detail-oriented, and committed to continuous improvement.
  • A genuine interest in mentoring and developing others.
Leadership & Soft Skills
  • Strong leadership and coaching abilities, especially in guiding junior team members.
  • Clear and confident communicator, capable of engaging technical and non-technical stakeholders alike.
  • Effective time manager with a proactive approach to project delivery and problem resolution.
  • Committed to engineering excellence and upholding the highest standards in quality.
Why Apply
  • Play a vital role in ensuring the safety and effectiveness of innovative medical technologies.
  • Join a team that values quality, collaboration, and continuous growth.
  • Work on mission-critical devices that make a difference in patient lives.
  • Enjoy a culture that prioritizes professional development, ownership, and performance.
Ready to Lead Quality in Medical Device Innovation?If you're a technically skilled quality professional who thrives in a collaborative environment and enjoys mentoring others while solving complex challenges — we’d love to hear from you.

Hero Recruitment