Design Assurance Engineer

Oxford Global Resources; Galway; On-site; EUR 55,000 - 75,000; Full time

Job summary

Oxford Global Resources in Galway seeks an experienced Design Assurance Engineer to support a quality remediation initiative, focusing on design controls, risk management, and test method validation within a medical device environment.

You will collaborate with R&D, Regulatory Affairs and Post Market QA, review DHF records, validate verification strategies, and help ensure transfers comply with internal and regulatory requirements. 12-month fixed term with potential extension.

Qualifications

• HETAC Level 8 (240 credits) in a STEM discipline with 2–4 years’ experience in a similar role.
• Experience 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.
• DHF Experience; Medical Device Background.

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.

Skills

Risk management

Design controls

Regulatory knowledge

Quality assurance

Teamwork

Education

HETAC Level 8 in STEM

Job description

Our 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
• DHF Experience required
• Medical Device Background

12 Months Fixed Term Contract with an extension