Senior Design Assurance Engineer

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

We are currently seeking a Senior Design Assurance Engineer to support an exciting phase of growth within a rapidly expanding medical device company based in Galway. In this role, you will play a key part in ensuring design quality, regulatory compliance, and the successful transfer of products into manufacturing, while contributing to the development of innovative medical technologies that have a direct impact on patient care.

You will work across a portfolio of products progressing towards FDA approval, helping to drive robust design assurance practices throughout the product development lifecycle and supporting the company's continued expansion in the global market.

This position suits someone who thrives in a fast-paced environment, enjoys ownership and accountability, and is motivated by delivering real-world results.

In this role you will work cross-functionally with engineering, manufacturing, and external partners to support the full product lifecycle.

Key responsibilities include:

• Supporting and leading Design Verification and Design Validation activities
• Leading or contributing to Corrective and Preventive Actions (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