R&D Design engineer (Medical Devices)

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