Senior Design Assurance Engineer — Med Devices

Actalent; Galway; On-site; EUR 70,000 - 100,000; Full time

Job summary

Actalent in Galway is seeking a Senior Design Assurance Engineer to support growth in a fast-moving medical device company. You will help ensure design quality, regulatory compliance, and the transfer of products into manufacturing while contributing to innovative medical technologies that improve patient care.

You will work across product lifecycles with engineering, manufacturing and external partners, lead verification and validation activities, CAPA investigations, and maintain Design

Qualifications

• 4+ years' experience in a design assurance or quality role.
• Experience with ISO 13485-compliant quality systems.
• Strong background in Design Controls and Design Reviews.

Responsibilities

• Supporting and leading Design Verification and Design Validation activities
• Leading or contributing to CAPA and root cause investigations
• Owning or supporting Design Controls, Design Reviews, and Design Change processes
• Developing and reviewing test methods, test protocols, and associated work instructions
• Contributing to technical documentation for regulatory submissions
• Collaborating with external suppliers, manufacturing partners, and design partners
• Influencing new product design, processes, and standards aligned with business strategy
• Degree (Level 8 or equivalent) in Engineering, Science, or a related discipline
• 4+ years' experience in a relevant design assurance engineering or quality roles
• Experience working within an ISO 13485-compliant Quality Management System
• Strong background in design Controls and Design Reviews

Job description

Actalent in Galway is seeking a Senior Design Assurance Engineer to support growth in a fast-moving medical device company. You will help ensure design quality, regulatory compliance, and the transfer of products into manufacturing while contributing to innovative medical technologies that improve patient care.

You will work across product lifecycles with engineering, manufacturing and external partners, lead verification and validation activities, CAPA investigations, and maintain Design