Job title: Design Assurance Engineer
Location: Galway West Business Park
Benefits: Competitive salary, Share options, excellent opportunity to develop your experience and career in an exciting start up helping develop a product from its very early stages.


Company:
My client an early-stage medical device start-up company focused on the design and development of novel devices for the treatment of Intracranial Atherosclerotic Disease. This is a new and evolving treatment area likely to be the next frontier in Neuro-intervention.


Overview:
As a Design Assurance Engineer you will be instrumental in ensuring the quality, safety, and regulatory compliance of our 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[1]paced start-up environment.



Responsibilities:
- Establish and maintain appropriate procedures to ensure compliance with regulatory requirements.
- 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.
- 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.
- 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.



Requirements:
- Bachelor's degree in engineering or a related technical field.Minimum of 2+ years of experience in design assurance or quality engineering within the medical device industry, preferably with neuro interventional devices



Does this sound like your next career move? To apply and For more info forward your application to the link provided or contact me on 087 0612325 OR thomas.gallagher@lifescience.ie