Exciting opportunity for an R&D Engineer for a Leitrim based medical device company.
The ideal candidate will have previous experience in the medical device or pharmaceutical industry with knowledge of manufacturing processes.
Role of this position
- Development of Products, Processes and Equipment, including product and material specifications, material sourcing, equipment and tooling specifications and sourcing, process development and testing, to develop new products for customers or the Company from concept to design freeze.
- Project manage all developments to ensure that all commitments are achieved including functional prototypes, delivery dates, design iteration samples, test protocols and reports, project costs and other project deliverables are achieved.
- Ensure full compliance with all Quality, Regulatory, Health and Safety and other relevant legislation. This will include the completion of Design History Files, Design Inputs, Outputs, Design Reviews, Log books, etc as necessary. Ensure full traceability of Design Development and control of changes.
- Ensure full and effective transfer of new products after Design Freeze to manufacturing areas ensuring that the product and processes are fully developed to allow product/process validation to begin. Provide comprehensive training to production, quality and technical staff to ensure a smooth production start including validations and records.
- Constantly review the development processes to ensure they are effective and compliant with the goal to achieve the optimum development cycles at minimum cost. Ensure Lean GROWTTH principles are followed especially 3P, 5S, DMAIC and 6 sigma.
- Third level Qualification in Engineering or Science.
- 2+ years previous experience in a medical devices or pharmaceutical environment
- Knowledge of medical device products and associated manufacturing processes, in particular with extrusion-based catheter assemblies is highly desirable.
- A Senior R&D Engineer position also exists for a candidate with a minimum of 4 years' experience. Additional duties may include: Management of PAO/Trainer/Technician/Associate/R&D Engineer.
- Design capability with CAD systems (Solid Edge) and MS Project desirable.
Please call Michelle Galvin today for further information on 091 373 938 or email: firstname.lastname@example.org
CareerWise Recruitment (In Search of Excellence)