Senior Design Quality Engineer (AI)

Location: Galway, Ireland; hybrid

Salary: €52,400–€82,915 per year, plus an annual bonus

Company

Johnson & Johnson MedTech develops healthcare and medical technology solutions to prevent, treat, and cure complex diseases.

What you will do

• Ensure design control and risk management activities comply with regulatory and company requirements.
• Support new product development, lifecycle management, design reviews, design transfer, launch planning, and post-market activities.
• Define design inputs and outputs, support verification, validation, process validation, and bench testing.
• Identify critical-to-quality requirements, manage risks and controls, and deliver quality outputs for R&D projects.
• Lead or support CAPA, nonconformance management, complaint investigations, audits, inspections, and quality system improvements.
• Partner with Product Development, Regulatory Affairs, Manufacturing, Marketing, and global cross-functional teams to resolve quality issues and maintain compliance.

Requirements

• Degree in engineering or another technical discipline.
• At least 5 years of experience in the medical device, IVD, or pharmaceutical industry.
• Experience with Quality Management Systems and design control processes.
• Strong knowledge of design control, risk management, sterilization, and quality assurance processes.
• Working knowledge of 21 CFR 820 and ISO 13485, with familiarity with global regulatory requirements and FDA or Notified Body inspections.
• Understanding of AI concepts and frameworks, responsible and ethical AI practices, and effective prompting techniques.

Culture & Benefits

• Collaborative and inclusive work environment focused on high-quality products and continuous improvement.
• Opportunities to contribute to innovative product development and grow technical expertise.
• Vacation days, parental leave of at least 12 weeks, bereavement leave, caregiver leave, and volunteer leave.
• Well-being reimbursement and programs supporting financial, physical, and mental health.
• Annual bonus, service anniversary and recognition awards, and eligibility for insurance plans subject to applicable terms.