Job title:
Senior Design Assurance Engineer
Location:
Galway- Hybrid
Job Type:
Full time- Permanent
Summary
Our Client in Galway City is looking to hire a Senior Design Assurance Engineer. The successful candidate will be reporting to the Director of Design Assurance. The role will collaborate with the development teams to enhance the companies new product portfolio, working predominantly on projects aimed at introducing or improving products for the treatment of a range of Stent systems. This is a fantastic opportunity, which will allow the successful candidate to work as part of a supportive, collaborative team.
Responsibilities:
- Work within the quality system and ensuring that the quality policy and company systems and procedures are complied with in line with the Medical Device Regulation 2017/745 , Medical Device Directive93/42/EEC, FDA Quality System Regulations 21 CFR Part 820, FDA GLP Regulation 21 CFR 58, ISO 13485, ISO 14971, Japanese Ministerial Ordinance # 169.
- Support the development / evolution of the company Design Control, Risk Management, and associated systems (e.g., labelling/packaging).
- Provide Design Assurance input to R&D project teams for designated projects.
- Support sustaining activities with a specific focus on design changes to meet business needs in line with updated standards and regulatory requirements and assess product impact with integration into QMS as required.
- Understand the Regulatory requirements for device developments and provide input to projects to encompass these requirements.
- Lead in specification development in relation to design input development.
- Participate in the generation of Design Input /Output documents.
- Lead the risk management activities for designated projects and design changes.
- Lead Human Factors / Usability Engineering activities and maintain Usability Engineering File for all products.
- Design, development and validation of test methods as required to support development programs.
- Develop and maintain design verification and validation plans, protocols and reports.
- Support R&D in the preparation and delivery of Design Reviews and associated checklists.
- Support the conduct of non-clinical studies at third party facilities in conjunction with R&D department.
- Establish and maintain the Design History File and associated documents.
- Provide DA support to R&D for equipment management and validation.
- Manage the labelling and packaging requirements of new and commercial products identifying upcoming changes to labelling and co-ordinate with R&D for timely implementation.
- Execute/ review gap analysis to standards, ASTMs and other associated documents and assess impact to product DHFs.
- Coaching and mentoring of colleagues and more junior members of the team.
Requirements:
- Bachelor's degree in Engineering, Science or related field is required.
- A minimum of five years’ relevant experience in the medical device industry preferably with Stent or class III device design assurance experience.
- An understanding of ISO 13485, ISO 14971 and FDA QSRs is a prerequisite.
- Experience with risk management, statistics, validation and physical testing is required.
- Excellent communication, organisational skills and the ability to present reports neatly and accurately is essential.
Should you require any support or assistance, please contact your local Gi Group office.
Gi Group Holdings Recruitment Limited are proud founding members of Menopause in business, pledge members for Neurodiversity in business, Disability committed members, Silver status pledge members for the Armed Forces Covenant, and Bronze trail blazers for Racial Equality matters.
Gi Group Holdings Recruitment Limited group of companies includes Gi Recruitment Limited, Draefern Limited, Gi Group Recruitment Ltd, INTOO (UK) Limited, Marks Sattin (UK) Limited, TACK TMI UK Limited, Grafton Professional Staffing Limited, Encore Personnel Services, Gi Group Ireland Limited and Kelly Services (UK) Ltd. Gi Group Ireland Limited are acting as an Employment Agency in relation to this role.
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