- Utilising 3D CAD Autodesk inventor for design, FEA etc.
- Producing BOM and assembly instructions.
- Producing V&V test plans and implementing.
- Contributing to IFU and service manuals.
- Producing key technical documents in conjunction with regulatory, such as FMEA/ Risk Management.
- Liaising with development workshop on producing prototypes.
- Liaising with manufacturing and purchasing on NPI & product improvement.
- Controlling and implementing engineering change notes or product variations.
- Excellent communication skills to effectively communicate with different functions of the business such as manufacturing, regulatory, marketing, purchasing, QA.
- Good understanding of mechanical engineering with knowledge of electronics/software (degree preferable)
- Experience of leading / contributing to project management for multiple concurrent projects
- Proficient in 3D CAD
- Ability to author and/or lead development of key documents within a technical file, e.g. RMF, Usability, V&V plans.
- A good understanding of the Design Engineer role/department in developing or making changes to medical devices.
- Proficient in 3D CAD Autodesk inventor.
- Trained/working knowledge of the following standards: ISO 14971, ISO 13485
- Trained/working knowledge of the following IEC standards: 60601-1, 60601-1-2, 60601-2-52, 62304, 62366-1
- A good understanding of welding techniques and influence on design.
- Ability to conduct in house testing in our bespoke test lab.
- Competent in the use of MRP system SAGE to build and maintain Bills of Materials.
- 25 days annual holiday plus bank holidays
- Free parking
- Free tea and coffee
- Company events
- Company pension