Senior Design Assurance Engineer

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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 or call .

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