14455Permanent Competitive Site Based Dublin, Ireland Updated on: 20-03-2025ROLE OVERVIEWWe are currently looking for a Principal Device Development Assurance Engineer to join a leading medical device company based in the Dublin area. As the Principal Device Development Assurance Engineer, you will be responsible for ensuring the highest standards in device development and compliance.KEY DUTIES AND RESPONSIBILITIES:Your duties as the Principal Device Development Assurance Engineer will be varied however the key duties and responsibilities are as follows:Support and provide guidance for device development programs through the design and development lifecycle for combination products, including prefilled pens, prefilled syringes, autoinjectors, and medical devices.Establish, maintain, and provide guidance on the contents of Design History Files for development programs, including associated activity plans and timelines.Collaborate with, and influence, affiliate sites, collaborators, and third parties to ensure appropriate objective evidence and controls are established and maintained in line with program deliverables.Support Risk Management activities for development programs through the implementation of ISO 14971:2019.ROLE REQUIREMENTS:To be successful in your application to this exciting role as the Principal Device Development Assurance Engineer we are looking to identify the following on your profile and past history:Relevant degree in engineering or science/life science.Extensive industry experience in medical device or pharmaceutical (with devices).A working knowledge and practical experience with device development and manufacturing operations activities for device or drug/device systems in a GMP environment.Key Words: Principal Device Development Assurance Engineer / Medical Device / Combination Products / Design Control / Quality Management System / ISO 13485 / ISO 14971 / GMP / Risk Management / Dublin / PharmaceuticalHyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer. We welcome applications from anyone who meets the role requirements. HRS exclusively supports the Life Science sectors, combining recruitment expertise with scientific knowledge to help you advance your career.
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