A Medical Device SME is looking to hire an experienced Design Assurance Engineer on a permanent basis, in Galway. The ideal candidate will have 5 years+ working within this area in a Medical Device environment.
Key Duties (full job spec available upon request)
- Lead key elements of the Design Review process in compliance with internal procedures including EU and FDA requirements.
- Maintain the Design History files, including managing the filing, storage, and retrieval of Design Quality Records.
- Work with research and development to establish design specifications and product requirements.
- Ensure all product quality standards and specifications are defined and achieved in line with company and regulatory requirements
- Lead key elements of the risk management process and preparation of risk management files including Hazard Analysis documents, Use FMEA, and Design FMEA.
- Identify product testing required and write design verification and validation plans
- Liaise with external vendors for product testing.
- Preparation of Standard Checklists for all the applicable harmonized standards.
- Generation and/or review of quality and technical documentation/change requests to support design activities.
- Routinely provides design assurance guidance and direction to engineers and/or technicians.
- Assist Regulatory with the compilation of design dossiers, technical files, essential requirements, and regulatory submissions documentation as required.
- Support various QA/RA activities including quality management, system reviews, internal & vendor audits, etc.
- Supports regulatory compliance/submission process.
What you need to have
- 5+ years experience in a similar role
- In-depth knowledge of the design control processes required for a Class III medical device
- Possess a Degree in engineering, biomedical or science degree
- Working knowledge of the Medical Device Directive (93/42/EEC)/Medical Device Regulation 2017/745 and FDA requirements including Quality System Regulation (21 CFR 820)
- Knowledge and demonstrated practice of risk management methodologies as per EN ISO14971.
- Experience with involvement in Regulatory submissions would be an advantage.
For a confidential discussion and more information on the role, please contact Elaine Dolan.