Design Assurance Engineer

We are seeking a talented and motivated Design Assurance Engineer to join our clients team in Galway. The Design Assurance Engineer will be instrumental in ensuring the quality, safety, and regulatory compliance of their neuro medical devices throughout the product development lifecycle. This role offers an exciting opportunity to contribute to groundbreaking advancements in neurological healthcare within a fast paced start-up environment.

 

Key Responsibilities

• Establish and maintain appropriate procedures to ensure compliance with regulatory
• Review/analyze whether current products and processes (including actions or decisions conducted) comply with standards such as the QSRs, ISO 13485, EU MDR, etc.
• Partners with R&D and other cross-functional partners to ensure the proper application of design controls, risk management, and the investigation/correction of design failures/challenges.
• Preparation of Standard Checklists for all the applicable regulatory standards.
• Performs Design Assurance activities including technical reviews of design documentation and labeling, attends design reviews, coordinates and facilitates completion and update of design risk management documentation.
• Assist when requested with the preparation of regulatory filings and subsequent correspondences on supporting submissions.
• Demonstrate an ability to apply, recommend and/or create quality tools and apply them effectively to a variety of business situations related to product development, manufacture and subsequent commercialization.
• Maintain detailed awareness and understanding of current regulations and regulatory guidance in regions of interest to development programs.
• Lead and support design control activities, including the development and maintenance of design plans, design inputs, design outputs, and design verification/validation protocols and reports.
• Conduct risk management activities, including the identification, assessment, and mitigation of design-related risks in accordance with regulatory requirements and industry standards. Plan, execute, and document verification and validation testing activities to demonstrate product performance and safety.
• Collaborate closely with cross-functional teams, including R&D, Regulatory Affairs, Clinical Affairs, and Manufacturing, to ensure alignment and coordination throughout the product development process.
• Maintain accurate and up-to-date design history files (DHF) and other design-related documentation in compliance with regulatory requirements.
• Identify opportunities for process improvement and drive initiatives to enhance design assurance practices and efficiency.

 

Requirements

• Bachelor's degree in engineering or a related technical field.
• Minimum of 3-5 years of experience in design assurance or quality engineering within the medical device industry, preferably with neuro interventional devices.
• Strong understanding of design control principles and regulations, including FDA QSR (21 CFR 820) and ISO 13485
• Experience with risk management methodologies, such as ISO 14971, and application to medical device development.
• Proficiency in verification and validation testing techniques, including protocol development, execution, and documentation.
• Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams.
• Detail-oriented with strong analytical and problem-solving abilities.
• Ability to work independently and manage multiple tasks simultaneously in a fast-paced, dynamic environment.

 

For further information on this role in Galway please contact Katie Kilbane on +353 86 1283368 or email network@hero.ie Check out all our open jobs on our HERO Recruitment website – https://www.hero.ie/

Please Note: Under its obligation under the Data Protection legislation, HERO Recruitment will not forward your details to any company without your prior approval. Data can only be transferred outside of the EEA on the basis of standards contractual clauses, to a country for whom an adequacy decision has been given by the European Commission or where the express permission of the data subject has been given. You have supplied us with your personal data in the process of applying for a position. Our client company may have personnel outside of the EEA who will review you data. We will apply the appropriate criteria in respect of the data transfer depending on the location of those personnel.