Principal R&D Engineer
This permanent job is available with a small medical device client of mine based in Galway. This company has moved into the next phase of development and are seeking a Principal R&D Engineer to join their established R&D team.
- Lead/Manage the R&D Engineers in the Product Development Group.
- 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.
- Gathering clinical/user needs and translation into technical specifications.
- Component/assembly design and preparation of associated drawings and specifications.
- Prototype and DV 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.
- Application of Engineering methodologies in device design and test method development
- Structured Problem Solving and Decision Making
- Translating clinical/user needs into technical specifications.
- Design Verification including product specific functional tests, Packaging & Transportation testing.
- Excellent working knowledge of statistical methods commonly used in product/process design and validation.
- Application of standard regulatory requirements
- Risk Management; Design and Use FMEA
- Project management through all phases of the Design & Development processes
- Excellent presentation, verbal and written communication skills.
- Change control management; design, process and system.
- Quality of Work; maintains high standards despite pressing deadlines.
Skills, Qualifications & Experience
- Mechanical Engineering degree or higher.
- Minimum 10 years’ experience in medical device design/development or similar role in a medical device company.
- Strong technical aptitude with a detailed understanding of fundamental engineering principals.
- Fundamental knowledge of materials (Nitinol, stainless steel, polymers) and processes used in medical devices.
- Fundamental knowledge of statistical analysis. Six Sigma Black Belt => “nice to have”.
- Knowledge and demonstrated practice of risk management methodologies as per EN ISO14971.
- Detailed knowledge (track record) of FDA requirements/submission (e.g. 510K approach) including Quality System Regulation (21 CFR 820), applicable harmonised standards and the ability to apply them in practice.
- Strong knowledge of applicable (ISO) standards.
- Working knowledge of the Medical Device Directive (93/42/EEC).
For more information, please contact Emma on 091 455 307.
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