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Building Bridges between Exceptional Contractors and Leading Clients
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.
Seniority level
* Mid-Senior level
Employment type
* Contract
Job function
* Engineering, Consulting, and Quality Assurance
Industries
* Medical Equipment Manufacturing
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