Senior Design Assurance Engineer

2 weeks ago


Galway, Galway, Ireland Life Science Recruitment Full time
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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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