Senior R&D Engineer
My client, a small but established medical device company, is looking for a Senior R&D Engineer to join their team. This experienced Engineer will have a background/experience in Mechanical Design in the medical device industry.
- Lead the Design and Development process for both new and transfer products in compliance to internal procedures including EU and FDA requirements from Development phase up to Transfer to Production.
- Gather clinical/user needs and translation into technical specifications.
- Component/assembly design and preparation of associated drawings and specifications.
- Prototype design, building and testing.
- Test method development; identification and procurement of equipment for inspection and test, test method validation and training.
- Generation, analysis and interpretation of test data.
- Developing and delivering project plans to performance, time and cost targets.
- Liaising with external resources to achieve project goals.
- Implement the risk management process and aid with the preparation of risk management files including Use and Design FMEAs as required in accordance with company procedures and EN ISO 14971.
- Identify product testing required, create design verification and validation plans, protocols and reports including specifically advising on sample sizing; Stability and Transportation testing
- Maintain the Design History files, including managing the filing, storage and retrieval of Design Quality Records in conjunction with Design Assurance.
- Generation and/or review of technical documentation / change requests to related to design activities.
Skills, Qualifications & Experience:
- Mechanical or Biomedical engineering degree or equivalent.
- Minimum 5 years’ experience in mechanical design/development or similar role in a medical device company.
- Strong technical aptitude with a good understanding of fundamental engineering principals and materials.
- Broad knowledge of materials and processes used in medical devices.
- Knowledge and demonstrated practice of risk management methodologies as per EN ISO14971.
- Working knowledge of the Medical Device Directive (93/42/EEC) and FDA requirements including Quality System Regulation (21 CFR 820), applicable harmonised standards and the ability to apply them in practice.
For more information, please contact Emma on 086 780 8679.
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