Your new company 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 ensuring compliance with ISO 13485 and regulatory standards (CE, EU MDR, UKCA, FDA).Your new roleAs an R&D Engineer, you will:Research user needs and market requirements to define product specifications.Design and develop components, subassemblies, and complete products using SolidWorks and advanced engineering tools.Create prototypes, manage BOMs, and oversee verification and validation testing.Lead design reviews, FMEA, and risk assessments.Collaborate with cross-functional teams including Manufacturing, Quality, Purchasing, and Product Management.Manage projects from concept through to post-launch, ensuring timelines and quality standards are met.Perform root cause analysis and implement engineering changes to resolve product issues.Ensure all documentation for Design History Files (DHF) and regulatory compliance is complete.What you'll need to succeedEssential Criteria:Bachelor's degree (2:1) in Mechanical Engineering, Product Design, or related discipline.Minimum 2 years' experience in mechanical or product design (medical field preferred).Proficiency in SolidWorks (mechanism design, surface modelling) and AutoCAD.Hands-on experience building prototypes and using engineering analysis tools (e.g., FEA).Strong understanding of ISO 13485 Quality Management System.Excellent problem-solving, project management, and communication skills.Desirable:Experience with PDM systems.Familiarity with regulatory requirements (CE, EU MDR, UKCA, FDA).Previous experience in medical device development.What you'll get in return Competitive salary and benefits package.Paid holidays, pension scheme, healthcare plan.Free on-site parking and canteen facilities.Career development and training opportunities.Employee perks and life assurance.What you need to do nowIf you're interested in this role, click 'apply now' to forward an up-to-date copy of your CV, or call us now.If this job isn't quite right for you, but you are looking for a new position, please contact us for a confidential discussion about your career.Hays Specialist Recruitment Limited acts as an employment agency for permanent recruitment and employment business for the supply of temporary workers. By applying for this job you accept the T&C's, Privacy Policy and Disclaimers which can be