Design Quality Assurance Engineer II – Medical Device (Product Development)

Location: Galway (Hybrid options available)
Type: Full-time, Permanent
Sector: Medical Device / Quality Engineering

Opportunity Overview

We are currently supporting a leading medical device client in their search for a Design Quality Assurance Engineer II to join their growing Quality Engineering function. This role focuses on supporting Design Control activities within a Product Development Process (PDP) environment, with initial involvement on a cutting balloon catheter project. The successful candidate will contribute to ensuring product safety, quality, and full regulatory compliance across design and development activities.

This position forms part of a wider Design Quality Assurance team responsible for an advanced product portfolio, including drug-coated stents, balloon dilatation catheters, and drug-coated or cutting balloons. The role may evolve to provide flexible support across multiple projects, including product improvement initiatives and design change implementation.

Key Responsibilities

• Apply knowledge of Design Control regulations to ensure full compliance across all project deliverables.

• Maintain and contribute to Design History File (DHF) documentation including design inputs, outputs, verification, validation, usability, risk management, and design reviews.

• Support cross-functional teams including R&D, Regulatory Affairs, Clinical, and Operations by providing quality and compliance input.

• Lead and manage design change activities, including project scoping, risk assessment, documentation updates, and implementation.

• Contribute to risk management documentation such as Hazard Analysis, Use Error Analysis, and Design FMEA.

• Support the resolution of quality issues including PIRs, CAPAs, and NCEPs.

• Ensure all design and development activities align with internal SOPs and external standards (e.g., ISO 13485, ISO 14971, FDA 21 CFR 820.30).

• Use structured problem-solving techniques to investigate and resolve design-related quality concerns.

• Collaborate with multi-disciplinary teams to continuously improve product and process quality.

Key Requirements

• Degree (Level 8 NFQ or equivalent) in a STEM discipline such as Engineering, Science, or related technical field.

• Minimum of 3 years' industry experience, ideally within medical devices or a regulated environment.

• Previous experience in Design Assurance, Product Development, or Design Control is highly desirable.

• Strong understanding of risk management processes, design verification/validation, and regulatory compliance.

• Confident communicator with strong documentation, organisation, and collaboration skills.

• Able to work effectively both independently and as part of a cross-functional team.

• Motivated to grow within a high-performance quality function and contribute to continuous improvement efforts.