Job Description
Hales Group are happy to be working alongside their clients to assist them in finding a Design Engineer to join their busy R&D Department. This role will involve working as part of the Design team to develop new products and improve existing designs, and to lead and author key documents within the technical file. Hours and Salary: This is a full-time position - 40 hours per week Monday-Friday, 8.30am - 5pm – Salary from £28,000 p/a, negotiable for the right experience. Reporting to: Head of Design, Quality and Regulatory Compliance. Duties Include:
* 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.
Candidate Attributes: Essential
* 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.
Desirable
* 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.
Company Benefits
* 25 days annual holiday plus bank holidays
* Free parking
* Free tea and coffee
* Company events
* Company pension
For more information, please apply by uploading a CV and one of our team will be in touch!