Med Tech Design Assurance Engineer – Galway

Oxford Global Resources; Galway; On-site; EUR 55,000 - 73,000; Full time

Job summary

Oxford Global Resources in Galway is seeking an experienced Design Assurance Engineer to support a quality remediation initiative in the Med Tech sector. The role emphasizes robust application of design controls, risk management, and test method validation to meet internal and regulatory requirements.

The position collaborates with R&D, Regulatory Affairs, Clinical, Medical Safety and QA teams to review DHF records and verify verification strategies, ensuring high-quality product development and

Qualifications

• Minimum 2–4 years in a similar role.
• Practical knowledge of 13485 and FDA part 820.
• Good technical capabilities and communication skills.

Responsibilities

• Interface with R&D, Regulatory Affairs, Clinical, Medical Safety and QA teams providing quality input.
• Review core DHF records.
• Evaluate verification strategies to confirm TMVs are in place.

Skills

Risk management

Design controls

Regulatory standards

Process change

Communication

Teamwork

Initiative

Education

HETAC Level 8 STEM

Job description

Oxford Global Resources in Galway is seeking an experienced Design Assurance Engineer to support a quality remediation initiative in the Med Tech sector. The role emphasizes robust application of design controls, risk management, and test method validation to meet internal and regulatory requirements.

The position collaborates with R&D, Regulatory Affairs, Clinical, Medical Safety and QA teams to review DHF records and verify verification strategies, ensuring high-quality product development and