Your newpany
Hays Engineering is working with a global leader in assistive technology, who are seeking an experienced R&D Engineer to join their dynamic design team. This role is pivotal in developing cutting-edge medical products that improve lives worldwide. You will work across all stages of product development—from concept and detailed design to verification, testing, and launch—while ensuringpliance with ISO 13485 and regulatory standards (CE, EU MDR, UKCA, FDA).
Your new role
As an R&D Engineer, you will:
1. Research user needs and market requirements to define product specifications.
2. Design and developponents, subassemblies, andplete products using SolidWorks and advanced engineering tools.
3. Create prototypes, manage BOMs, and oversee verification and validation testing.
4. Lead design reviews, FMEA, and risk assessments.
5. Collaborate with cross-functional teams including Manufacturing, Quality, Purchasing, and Product Management.
6. Manage projects from concept through to post-launch, ensuring timelines and quality standards are met.
7. Perform root cause analysis and implement engineering changes to resolve product issues.
8. Ensure all documentation for Design History Files (DHF) and regulatorypliance isplete.
What you'll need to succeed
Essential Criteria:
9. Bachelor’s degree (2:1) in Mechanical Engineering, Product Design, or related discipline.
10. Minimum 2 years’ experience in mechanical or product design (medical field preferred).
11. Proficiency in SolidWorks (mechanism design, surface modelling) and AutoCAD.
12. Hands-on experience building prototypes and using engineering analysis tools (, FEA).
13. Strong understanding of ISO 13485 Quality Management System.
14. Excellent problem-solving, project management, andmunication skills.
Desirable:
15. Experience with PDM systems.
16. Familiarity with regulatory requirements (CE, EU MDR, UKCA, FDA).
17. Previous experience in medical device development.
What you'll get in return
18. Paid holidays, pension scheme, healthcare plan.
19. Free on-site parking and canteen facilities.
20. Career development and training opportunities.
21. Employee perks and life assurance.