Senior R&D Engineer
Senior R&D Engineer
- Engineering Qualification in Design, Polymer, Medical, Mechanical, Biomedical or equivalent.
- Minimum 5 years experience in Catheter and Medical Device design and extensive knowledge on the use and requirements for Catheter design. Comprehensive knowledge of resins, materials, packaging and other components required for Catheter and Medical Device Design.
- Comprehensive knowledge of the manufacturing processes used for manufacturing catheters used within the Neurovascular together with stent delivery systems for the Cardiovascular and Peripheral vascular areas, including extrusion, moulding, balloon forming, braiding, packaging and other assembly techniques.
- Solid modelling and CAD skills
- ISO and FDA standards for Catheter and Medical Device Design
- ISO and FDA standards for Design control including Design Inputs, Outputs, Design Verification
- Organisation of Clinical Trials etc.
- Knowledge of Sterilisation methods and associated material selection criteria.
- Rapid Prototyping Techniques.
- Process Product validation requirements.
- Designing innovative catheters and Medical Devices to meet and exceed the requirements of our Customers. Selection and design of materials, components, tubing and packaging.
- Working with the New Product Introduction teams to ensure Product Designs include DFM (Design for Manufacture) and can be manufactured at competitive costs.
- Working with the Business Acquisition teams to design products to meet or exceed the scope of Customer requirements.
- Compliance with the requirements of FDA and ISO standards for Catheters and Medical Devices
- Planning and co-ordinating New Product Design to include Design Inputs, Design Outputs, Design Verification and Design Validation including, where necessary, Clinical trials, Technical Files, Technical Reports and Design History Files in accordance with our clients procedures and Regulatory Standards.
- Especially in the area of New Products but also existing products, participation in areas such as Customer Complaints, CAPA’s, etc. by providing technical support, as required.
- Meeting the agreed timelines on Designs and other associated outputs.
- Organising the manufacture of prototypes, as required.
- Leading or participating in design tasks such as clinical trials, functional studies, testing including biocompatibility, aging, design verification, etc.
- Completing other tasks as assigned.
For further information on this Senior R&D Engineer role in Leitrim please contact Amanda Reynolds on 0860468858/ email@example.com
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