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Senior Design Assurance Engineer
Our client, a Galway-based Medical Device company, is currently seeking a Senior Design Assurance Engineer. Reporting to the Design Assurance Manager, the successful candidate will focus on the development of new technologies.
Role/Responsibilities
* Work within the quality system, ensuring compliance with the Medical Device Directive 93/42/EEC, 2007/47/EC, Medical Device Regulation 2017/745, FDA Quality System Regulations 21 CFR § 820, FDA GLP Regulation 21 CFR § 58, FDA Labelling Regulation 21 CFR § 801, ISO 13485, ISO 14971, Japanese Ministerial Ordinance # 169.
* Support development and evolution of Design Control, Risk Management, and related systems for new product development technologies.
* Provide Design Assurance input to R&D project teams, understanding regulatory requirements and incorporating them into projects.
* Lead specification development and participate in generating Design Input/Output documents.
* Lead risk management activities for projects and design changes.
* Design, develop, and validate test methods to support development programs.
* Develop and maintain design verification and validation plans, protocols, and reports.
* Support R&D in preparing and delivering Design Reviews and checklists.
* Support execution of non-clinical studies at third-party facilities.
* Establish and maintain the Design History File and related documents.
* Provide QA support for equipment management in R&D.
* Execute assigned project aspects.
* Mentor and support Design Assurance engineers.
* Ensure readiness for audits and act as a design assurance representative during audits.
* Address and close non-conformances effectively.
* Support sustaining activities as assigned.
Skills/Experience
* A degree in Engineering, Science, or related field.
* Over 5 years of relevant experience in the medical device or pharmaceutical industry, preferably with Stent and Stent Coating technology.
* Understanding of ISO 13485, ISO 14971, and FDA QSRs.
* Familiarity with statistics, validation, and physical testing.
* Good communication and organizational skills, with the ability to present reports clearly and accurately.
For further information, please contact James Cassidy at james.cassidy@lifescience.ie or call 0860204322.
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