Design Assurance Engineer

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

Client industry: Med tech

Schedule: Full-time

Position: Design Assurance Engineer

Location: Galway

Start date: ASAP

LOA: 12 months fixed term initially

On site/remote: on-site

Languages: English

Job Description

My client in Galway are seeking an experienced Design Assurance Engineer to join their team and fulfil Quality Assurance responsibilities as part of a quality remediation initiative. The position will focus on ensuring robust application of design controls, risk management, and test method validation.

Key Responsibilities

• Interface with R&D, Regulatory Affairs, Clinical, Medical Safety, Complaints Management Centres and Post Market Quality Assurance team environment providing technical and quality systems input.
• Review core DHF records
• Evaluate verification strategies to confirm that approved TMVs are in place and align with global work instructions
• Familiarity with requirements and procedures that govern medical device Design Control
• Understanding of Design Assurance requirements to ensure new product/technology transfers comply to all internal and regulatory requirements.
• Identify and resolve complex exceptions to work assignments.
• Seek to support improvements in product and process quality.
• Provides both quality and technical input to ongoing product development and post market commercial product activities.

Key Requirements

• HETAC Level 8 (240 credits) in a STEM discipline with a minimum of 2-4 years’ experience in a similar role.
• Experienced in risk management, design and process change, standards compliance (to regulatory requirements).
• Practical knowledge of 13485 and FDA part 820.
• Good technical capabilities, communication skills, teamwork abilities and initiative.
• Proven ability to work well as part of a team & on own with minimum supervision