ROLE PURPOSE Reporting to the Head of Research & Development (R&D), the Design Engineer presents ideas and solutions by applying a highly advanced level of specialist, detailed technical expertise to problem solving across both sides of the business (Pressure ulcer prevention & Falls Management). They are responsible for the design and development of innovative, market leading concepts and lead on assigned projects. They will plan and lead allocated projects within the R&D team, contributing to on time and budget delivery, adapting to changing circumstances promptly. The Design Engineer creates and maintains a Design History File (DHF) and other regulatory driven documentation requirements and delivers project credibility through structured development via prototyping, testing, verification, and validation. KEY TASKS & ACCOUNTABILITIES * Produce new ideas, approaches, or insights to create innovative designs through prototyping, testing & product development. * Utilise CAD to produce models, assemblies, engineering drawings (including dimensioning & tolerancing) and FEA. * Controlled implementation of documented changes in aims to improve product quality & manufacturing efficiencies. * Project management and lead on allocated R&D projects including project planning, scheduling, budgeting, and management of the project team to fulfil project goals. * Where applicable, comply with [current version] Research, Development & Design Control procedure and maintain required project documentation detailing analysis of processes and testing. * Leads on device technical files conducting remediation work where required to ensure MRD CE Marking compliance. * Support notified body technical questions as a result of audits or technical file submissions. * Identify need and select standard product testing as required. * Develop & implement product & process testing, verification, and validation protocols. * Identify & implement testing, verification, and validation of designs. * Analysis of testing, verification, and validation data. * Testing, verification, and validation report writing. * Conduct design risk management to a high level and understanding. * Signature and approver of all above reports. * Complies with policies, legal and regulatory obligations. Ensures that the design control process is adhered to according to EN ISO 13485: [current version]. * Able to suggest improvements to working practices and procedures primarily within the department but within the company too. * Where applicable, provide mentorship and professional guidance for more junior colleagues. * Prepare & manage project meetings both internally & externally e.g., suppliers, key opinion leaders etc. Skills, Qualifications and Experience * Experience: At least 2 years within the medical devices industry. * Experienced in CAD modelling & assemblies with the ability to undertake FEA and produce high quality manufacturable engineering drawings & robust designs. * Experience of working within a EN ISO 13485: [current version] Quality Management System. * Experienced in creation of technical files to support product families/groups. * Experienced in deign testing, verification and validation. * Experienced in design risk management to 14971 [current version]. * Experienced in usability engineering studies. Knowledge: Strong understanding of EU MDR, as well as international standards & regulations (ISO 13485:2016 & FDA 21 CFR Part 820 etc.) would be very advantageous. Travel: UK drivers’ licence & willingness to travel between company and customer sites as and when required