Design Assurance Engineer

• Contractor Role
• Medical Device

This job posting is for a Design Assurance Engineer Contract Role based in Galway, Ireland, with a hybrid working arrangement. The successful candidate will be part of a Sustaining Engineering team responsible for supporting Drug Eluting Stent and Cutting Balloon products, contributing to post-market activities, ensuring compliance, and enhancing product quality. Below is a summary of key information:

Job Purpose

The role involves:

• Ensuring patient safety, customer satisfaction, and product quality.
• Compliance with quality systems and applicable regulations.
• Risk mitigation in design, use, and manufacturing.
• Adherence to training and regulatory requirements.

Key Responsibilities

General

• Work under limited supervision while liaising with cross-functional teams (R&D, Regulatory, Clinical, etc.).
• Understand and follow procedures for medical device Design Control, Risk Management, and Post Market Surveillance.
• Resolve complex issues, support quality/process improvements, and ensure adherence to quality requirements.
• Exhibit strong communication, interpersonal, and leadership skills.

Technical

• Provide design quality support for post-market commercial products.
• Address issues like complaints, CAPAs, VIPs, and regulatory changes.
• Perform risk management, analyze data, and make informed decisions.
• Ensure compliance with regulatory standards.

Leadership

• Actively contribute to the team’s success in sustaining engineering and post-market activities.
• Promote best practices and support change initiatives within the project/department.

 

Qualifications & Experience

• HETAC Level 8 in a STEM discipline (240 credits) with 3-4 years of relevant experience.
• Strong technical and analytical skills, with proven problem-solving abilities.
• Effective communication, teamwork, and the ability to work independently.
• Familiarity with medical device quality systems and regulatory requirements.