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